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Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

Primary Purpose

Heart Failure With Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AccuCinch Ventricular Restoration System
Guideline-Directed Medical Therapy
Sponsored by
Ancora Heart, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction (HFrEF) focused on measuring Heart Failure, Reduced Ejection Fraction, Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-years or older
  2. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
  3. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
  4. Symptom Status:

    1. NYHA III,
    2. NYHA ambulatory IV, or
    3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
  5. Able to complete six-minute walk test with distance between 100 m and 450 m.
  6. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented.

    1. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments
    2. When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change
    3. When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters)
    4. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
    5. When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change
    6. If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition
    7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
    8. If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters)
    9. When applicable, for guideline-directed device-based therapies: a CRT device must be placed > 90 days before the screening TTE and CT, and an ICD must be placed > 30 days before the screening TTE and CT
  7. Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule

Exclusion Criteria:

Cardiovascular

  1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
  2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
  4. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
  5. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)
  6. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
  7. Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)
  8. Active bacterial endocarditis
  9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE
  10. Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy
  11. History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke

    Valvular

  12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
  13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
  14. Prior mitral or aortic valve replacement
  15. Tricuspid regurgitation grade 4+ (severe)
  16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec)
  17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)

    Procedural

  18. Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath)
  19. Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)
  20. Subjects in whom anticoagulation during the procedure is contraindicated
  21. Subjects in whom 90 days of antiplatelet therapy is contraindicated
  22. Known allergy to nitinol, polyester, or polyethylene
  23. Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure

    General

  24. Life expectancy <1 year due to non-cardiac conditions
  25. Currently participating in another interventional investigational study
  26. Subjects on high dose steroids or immunosuppressant therapy
  27. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

Sites / Locations

  • Grandview Medical Group Research, LLCRecruiting
  • University of Alabama at Birmingham
  • Phoenix Cardiovascular Research GroupRecruiting
  • Tucson Medical CenterRecruiting
  • Baptist Health Heart Failure & Transplant Institute
  • University of California San DiegoRecruiting
  • Scripps HealthRecruiting
  • University of Southern CaliforniaRecruiting
  • Kaiser Permanente San FranciscoRecruiting
  • University of California, San FranciscoRecruiting
  • University of Colorado
  • Hartford HealthRecruiting
  • Yale UniversityRecruiting
  • Medstar Health Research InstituteRecruiting
  • JFK Medical CenterRecruiting
  • HCA Florida Largo Hospital
  • University of MiamiRecruiting
  • Ascension Sacred Heart
  • Tampa General HospitalRecruiting
  • Emory UniversityRecruiting
  • Piedmont Heart Institute
  • Northwestern UniversityRecruiting
  • University of Chicago Medical CenterRecruiting
  • Advocate Good Samaritan HospitalRecruiting
  • Norton Heart Specialists
  • Our Lady of the Lake Regional Medical Center
  • Cardiovascular Institute of the SouthRecruiting
  • Northern Light Eastern Maine Medical CenterRecruiting
  • University of Maryland Medical Center
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of Massachusetts
  • University of MichiganRecruiting
  • Spectrum HealthRecruiting
  • William Beaumont HospitalRecruiting
  • Minneapolis Heart Institute FoundationRecruiting
  • University of MinnesotaRecruiting
  • Jackson Heart ClinicRecruiting
  • Washington University in St. LouisRecruiting
  • Deborah Heart & Lung
  • Hackensack University Medical CenterRecruiting
  • Morristown Medical CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • University at BuffaloRecruiting
  • Northwell HealthRecruiting
  • Mount Sinai HospitalRecruiting
  • CUMC/New York Presbyterian HospitalRecruiting
  • Weill Cornell Medicine-New York Presbyterian HospitalRecruiting
  • Vassar Brothers Medical CenterRecruiting
  • St. Francis HospitalRecruiting
  • NC Heart and Vascular Research, LLC
  • The Christ HospitalRecruiting
  • UH Cleveland Medical Center
  • Cleveland ClinicRecruiting
  • Ohio State UniversityRecruiting
  • INTEGRIS Baptist Medical CenterRecruiting
  • Oklahoma Heart HospitalRecruiting
  • Oklahoma Heart InstituteRecruiting
  • Providence St. Vincent Medical CenterRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Geisinger Clinic
  • Pinnacle Health Cardiovascular InstituteRecruiting
  • Penn State Hershey Medical CenterRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Allegheny General HospitalRecruiting
  • UPMC Heart and Vascular InstituteRecruiting
  • Rhode Island HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Prisma Health
  • Tennova Healthcare-Turkey Creek Medical Center
  • Ascension Saint ThomasRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Austin HeartRecruiting
  • Houston HeartRecruiting
  • Baylor College of Medicine St. Luke's Medical CenterRecruiting
  • Houston Methodist Hospital
  • UT HealthRecruiting
  • Texas Tech University Health Sciences CenterRecruiting
  • Baylor Scott & White
  • Methodist Healthcare System, San AntonioRecruiting
  • Intermountain Medical CenterRecruiting
  • University of Virginia Health SystemRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • CJW Chippenham Medical CenterRecruiting
  • Carilion Roanoke Memorial HospitalRecruiting
  • Valley Health WinchesterRecruiting
  • University of Washington
  • Providence Sacred Heart Medical CenterRecruiting
  • CAMC Clinical Trials Center
  • Aurora St. Luke's Medical CenterRecruiting
  • Medical College of Wisconsin
  • Republican Scientific and Practical Centre of CardiologyRecruiting
  • OLV Heart CentreRecruiting
  • AZ Sint-Jan-Oostende AV Campus BruggeRecruiting
  • St. Anne's University Hospital
  • Na Homolce Hospital
  • Hôpital de la Timone
  • CHU de Rennes - Hôpital Pontchaillou
  • Clinique-Pasteur
  • St. Antonius Ziekenhuis
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device group: AccuCinch Ventricular Restoration System

Control group: Guideline-Directed Medical Therapy

Arm Description

Subjects in this arm will receive the AccuCinch Ventricular Restoration System

Subjects in this arm will receive guideline-directed medical therapy (GDMT)

Outcomes

Primary Outcome Measures

Freedom from device- or femoral artery access-related major adverse events (MAE)
MAE defined as: All-cause death, Myocardial infarction, Stroke, Need for non-elective cardiovascular surgery, Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours Acute kidney injury requiring renal replacement therapy
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score
Higher scores in the KCCQ reflect better health status
6-Minute Walk Test (6MWT) distance (m)
Change in 6MWT distance (m) from baseline
Freedom from device- or femoral artery access-related major adverse events (MAE)
MAE defined as: All-cause death, Myocardial infarction, Stroke, Need for non-elective cardiovascular surgery, Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours Acute kidney injury requiring renal replacement therapy
A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method

Secondary Outcome Measures

Number of all-cause deaths or all-cause hospitalizations
Number of all-cause deaths
Number of all-cause hospitalizations
Incidence of all serious adverse events, including device- and procedure- related complications
Changes from baseline in New York Heart Association (NYHA) functional class
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Higher scores in the KCCQ reflect better health status
Changes from baseline in 6-Minute Walk Test (6MWT)
Measure in meters
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Rate and number of cardiovascular death events
Rate and number of heart failure death events
Rate and number of heart failure-related hospitalizations

Full Information

First Posted
March 30, 2020
Last Updated
October 2, 2023
Sponsor
Ancora Heart, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04331769
Brief Title
Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Official Title
Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
June 21, 2024 (Anticipated)
Study Completion Date
December 21, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ancora Heart, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
Detailed Description
The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System. Subjects will be randomized in a 1:1 ratio: Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n~200) Control group: Guideline-directed medical therapy (GDMT) (n~200)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy
Keywords
Heart Failure, Reduced Ejection Fraction, Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device group: AccuCinch Ventricular Restoration System
Arm Type
Experimental
Arm Description
Subjects in this arm will receive the AccuCinch Ventricular Restoration System
Arm Title
Control group: Guideline-Directed Medical Therapy
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive guideline-directed medical therapy (GDMT)
Intervention Type
Device
Intervention Name(s)
AccuCinch Ventricular Restoration System
Intervention Description
AccuCinch Ventricular Restoration System
Intervention Type
Drug
Intervention Name(s)
Guideline-Directed Medical Therapy
Intervention Description
Guideline-Directed Medical Therapy
Primary Outcome Measure Information:
Title
Freedom from device- or femoral artery access-related major adverse events (MAE)
Description
MAE defined as: All-cause death, Myocardial infarction, Stroke, Need for non-elective cardiovascular surgery, Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours Acute kidney injury requiring renal replacement therapy
Time Frame
180 days
Title
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score
Description
Higher scores in the KCCQ reflect better health status
Time Frame
180 days
Title
6-Minute Walk Test (6MWT) distance (m)
Description
Change in 6MWT distance (m) from baseline
Time Frame
180 days
Title
Freedom from device- or femoral artery access-related major adverse events (MAE)
Description
MAE defined as: All-cause death, Myocardial infarction, Stroke, Need for non-elective cardiovascular surgery, Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours Acute kidney injury requiring renal replacement therapy
Time Frame
365 days
Title
A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Description
A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Number of all-cause deaths or all-cause hospitalizations
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Number of all-cause deaths
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Number of all-cause hospitalizations
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Incidence of all serious adverse events, including device- and procedure- related complications
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Changes from baseline in New York Heart Association (NYHA) functional class
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Description
Higher scores in the KCCQ reflect better health status
Time Frame
30 days, 90 days, 365 days, 545 days, 730 days
Title
Changes from baseline in 6-Minute Walk Test (6MWT)
Description
Measure in meters
Time Frame
30 days, 90 days, 365 days, 545 days, 730 days
Title
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time Frame
30 days, 90 days, 365 days, 730 days
Title
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time Frame
180 days
Title
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time Frame
30 days, 90 days, 365 days, 730 days
Title
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time Frame
180 days
Title
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time Frame
30 days, 90 days, 365 days, 730 days
Title
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time Frame
180 days
Title
Rate and number of cardiovascular death events
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Rate and number of heart failure death events
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Rate and number of heart failure-related hospitalizations
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Other Pre-specified Outcome Measures:
Title
Changes from baseline in mitral effective regurgitant orifice area (EROA)
Time Frame
30 days, 90 days, 180 days, 365 days, 730 days
Title
Changes from baseline in left atrial strain measured by Echo
Time Frame
30 days, 90 days, 180 days, 365 days, 730 days
Title
Changes from baseline in left ventricular global longitudinal strain measured by Echo
Time Frame
30 days, 90 days, 180 days, 365 days, 730 days
Title
Changes from baseline in right ventricular free wall longitudinal strain measured by Echo
Time Frame
30 days, 90 days, 180 days, 365 days, 730 days
Title
Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains
Description
Higher scores in the KCCQ reflect better health status
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire
Description
Lower scores in the EQ-5D-5L reflect better health status
Time Frame
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Title
Changes from baseline in right ventricular (RV) fractional area change measured by Echo
Description
Measured by percent change
Time Frame
30 days, 90 days, 180 days, 365 days, 730 days
Title
Changes from baseline in tricuspid annular plane systolic excursion (TAPSE) measured by Echo
Description
Measured in centimeters or millimeters
Time Frame
30 days, 90 days, 180 days, 365 days, 730 days
Title
Changes from baseline in tricuspid regurgitation measured by Echo
Description
Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL)
Time Frame
30 days, 90 days, 180 days, 365 days, 730 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-years or older Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab Symptom Status: NYHA III, NYHA ambulatory IV, or NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent) Able to complete six-minute walk test with distance between 100 m and 450 m. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters) When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters) When applicable, for guideline-directed device-based therapies: a CRT device must be placed > 90 days before the screening TTE and CT, and an ICD must be placed > 30 days before the screening TTE and CT Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule Exclusion Criteria: Cardiovascular Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent Untreated clinically significant coronary artery disease (CAD) requiring revascularization Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis) Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures) Active bacterial endocarditis Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke Valvular Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe) Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable) Prior mitral or aortic valve replacement Tricuspid regurgitation grade 4+ (severe) Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec) Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe) Procedural Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath) Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2) Subjects in whom anticoagulation during the procedure is contraindicated Subjects in whom 90 days of antiplatelet therapy is contraindicated Known allergy to nitinol, polyester, or polyethylene Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure General Life expectancy <1 year due to non-cardiac conditions Currently participating in another interventional investigational study Subjects on high dose steroids or immunosuppressant therapy Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Zapien, MS, CCRA
Phone
408-727-1105
Email
mzapien@ancoraheart.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Leon, MD
Organizational Affiliation
Columbia University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulrich P Jorde, MD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Reisman, MD
Organizational Affiliation
New York Presbyterian/Weill Cornell Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grandview Medical Group Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Thorington, RN
Phone
205-971-7578
Email
Susan.thorington@grandviewhealth.com
First Name & Middle Initial & Last Name & Degree
Juan Bernal, MD
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Houston
Email
scarlson@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Mustafa Ahmed, MD
Facility Name
Phoenix Cardiovascular Research Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Byrne
Phone
602-952-0002
Ext
7349
Email
JESSICA.BYRNE@abrazohealth.com
First Name & Middle Initial & Last Name & Degree
Timothy Byrne, DO
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Elias Calles, MPH
Phone
520-324-5512
Email
natalia.eliascalles@tmcaz.com
First Name & Middle Initial & Last Name & Degree
Thomas E. Waggoner, DO
Facility Name
Baptist Health Heart Failure & Transplant Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Ford-Bland
Email
amy.ford-bland@baptist-health.org
First Name & Middle Initial & Last Name & Degree
Patrick Campbell, MD
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maylene Alegre
Phone
858-246-2511
Email
malegre@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Jorge Silva Enciso, MD
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Gil-Flamer
Email
Gil-Flamer.John@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Matthew Price, MD
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Ramos
Phone
818-309-5542
Email
Melissa.ramos@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Ajay Vaidya, MD
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quyen Chau
Phone
415-833-3468
Email
Quyen.x.chau@kp.org
First Name & Middle Initial & Last Name & Degree
Van Selby, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Furrier
Phone
415-476-4922
Email
Jacqueline.Furrier@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Liviu Klein, MD
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hartford Health
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Roman
Phone
860-972-1558
Email
William.Roman@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Bryan Piccirillo, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Levesque, RN
Phone
203-737-6483
Email
Linda.levesque@yale.edu
First Name & Middle Initial & Last Name & Degree
Lavanya Bellumkonda, MD
Facility Name
Medstar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Curl
Email
Megan.A.Curl@medstar.net
First Name & Middle Initial & Last Name & Degree
Sriram Rao, MD
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Bengco-Catalano
Email
Abigail.Catalano@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Waqas Ghumman, MD
Facility Name
HCA Florida Largo Hospital
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saurabh Sanon, MD
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Lang
Phone
305-298-4471
Email
BLang@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Mrudula Munagala, MD
Facility Name
Ascension Sacred Heart
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Corlies
First Name & Middle Initial & Last Name & Degree
Rohit Amin, MD
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thanh Tran
Email
tqtran@usf.edu
First Name & Middle Initial & Last Name & Degree
Fadi Matar, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristy Pitts
Phone
404-686-5775
Email
klpitts@emory.edu
First Name & Middle Initial & Last Name & Degree
Kendra Grubb, MD
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Withdrawn
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Chappell
Phone
312-926-7312
Email
Meredith.Chappell@nm.org
First Name & Middle Initial & Last Name & Degree
James Flaherty, MD
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Herzog
Email
vherzog@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Gene Kim, MD
Facility Name
Advocate Good Samaritan Hospital
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Lux
Phone
630-730-6343
Email
Jillian.Lux@aah.org
First Name & Middle Initial & Last Name & Degree
Dominick Bufalino, MD
Facility Name
Norton Heart Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40216
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Abell
First Name & Middle Initial & Last Name & Degree
Kelly McCants, MD
Facility Name
Our Lady of the Lake Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micah Klumpp, Ph.D
Phone
225-526-0430
Email
micah.klumpp@fmolhs.org
First Name & Middle Initial & Last Name & Degree
Jorge Castellanos, MD
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deanna Benoit, LPN, CCRC
Phone
985-873-5613
Email
Deanna.Benoit@cardio.com
First Name & Middle Initial & Last Name & Degree
Jennifer Aucoin, LPN, CCRC
Phone
985-873-5037
Email
Jennifer.aucoin@cardio.com
First Name & Middle Initial & Last Name & Degree
Peter Fail, MD
Facility Name
Northern Light Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christa Balmas
Email
cbalmas@northernlight.org
First Name & Middle Initial & Last Name & Degree
Matthew McKay, MD
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert J Hicks, III, MD, MPH
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Fu
Email
LFU2@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Ignacio Inglessis-Azuaje, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Tyler, MSRN, FNP-c
Phone
617-632-7727
Email
ptyler@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jenifer Kaufman, RN, MS
Phone
617-632-8956
Email
jmkaufma@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Arthur Rashad Garan, MD
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenna Nickerson
Email
jenna.nickerson@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Nikolaos Kakouros, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Schley
Email
schleya@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Abbas Bitar, MD
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Helm
Phone
616-486-2080
Email
Elizabeth.Helm@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Sangjin Lee, MD
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diedre Brunk
Email
Diedre.brunk@beaumont.org
First Name & Middle Initial & Last Name & Degree
Ivan Hanson, MD
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari Thomas
Email
Kari.M.Thomas@allina.com
First Name & Middle Initial & Last Name & Degree
Peter Eckman, MD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Longman
Email
longm021@umn.edu
First Name & Middle Initial & Last Name & Degree
Gregory Helmer, MD
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Neal, RN
Phone
602-982-7850
Email
JNeal@jacksonheart.com
First Name & Middle Initial & Last Name & Degree
William Crowder, MD
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Flanagan
Phone
314-454-7451
Email
jflanaga@wustl.edu
First Name & Middle Initial & Last Name & Degree
Justin Vader, MD
Facility Name
Deborah Heart & Lung
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew McElvarr
Email
mcelvarra@deborah.org
First Name & Middle Initial & Last Name & Degree
Richard Kovach, MD
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Castillo
Email
manuel.castillo@hmhn.org
First Name & Middle Initial & Last Name & Degree
Tilak Pasala, MD
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Agar
Phone
973-971-4205
Email
Diane.agar@atlantichealth.org
First Name & Middle Initial & Last Name & Degree
Philippe Genereux, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Persaud
Email
napersaud@montefiore.org
First Name & Middle Initial & Last Name & Degree
Yogita Rochlani, MD
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Stein
Email
rmstein3@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, MD
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Ragusa
Email
gragusa@northwell.edu
First Name & Middle Initial & Last Name & Degree
Gerin Stevens, MD
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betsy Ellsworth, MSN, ANP
Phone
212-824-8902
Email
Betsy.ellsworth@mountsinai.orgorg
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Facility Name
CUMC/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Dalton
Phone
212-342-1820
Email
keb2114@columbia.edu
First Name & Middle Initial & Last Name & Degree
Gabriel Sayer, MD
Facility Name
Weill Cornell Medicine-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Reynolds
Phone
212-746-4617
Email
Dtr2001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Mark Reisman, MD
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Rausch
Phone
845-483-6323
Email
William.rausch@nuvancehealth.org
First Name & Middle Initial & Last Name & Degree
Rajeev Narayan, MD
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Krug, MA, RN CCRC
Phone
516-562-6722
Email
patricia.krug@chsli.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Haag, RN, MPA, CCRP
Phone
516-662-4512
Email
Elizabeth.Haag@chsli.org
First Name & Middle Initial & Last Name & Degree
George Petrossian, MD
Facility Name
NC Heart and Vascular Research, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Pierre-Louis
First Name & Middle Initial & Last Name & Degree
Robert Lee Jobe, MD,
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Krabbe
Phone
513-585-1777
Email
denise.krabbe@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
Dean Kereiakes, MD
Facility Name
UH Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Marie Simmons
Email
SIMMONA8@ccf.org
First Name & Middle Initial & Last Name & Degree
Rishi Puri, MD PhD FRACP
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexa Coressel
Phone
614-247-7133
Email
Alexa.Coressel@osumc.edu
First Name & Middle Initial & Last Name & Degree
Konstantinos D Boudoulas, MD
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dellia Dion
Email
Dellia.Dion@integrisok.com
First Name & Middle Initial & Last Name & Degree
Douglas Horstmanshof, MD
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacie Hanes, APRN-CNS, CCRN, CCRC
Phone
405-608-1283
Email
shanes@okheart.com
First Name & Middle Initial & Last Name & Degree
Donna Grossman, RN, CCRC
Phone
405-608-1272
Email
dgrossman@okheart.com
First Name & Middle Initial & Last Name & Degree
Mohammad Ghani, MD
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynette Tramell
Email
Lynette.tramell@oklahomaheart.com
First Name & Middle Initial & Last Name & Degree
Kamran Muhammad, MD
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Jackson
Email
Sarah.Jackson3@providence.org
First Name & Middle Initial & Last Name & Degree
Jacob Abraham, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Halvorson
Phone
503-418-1679
Email
halvorsj@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Johannes Steiner, MD
Facility Name
Geisinger Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Kilbride
Phone
570-271-8492
Email
sakilbride@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Shikhar Agarwal, MD
Facility Name
Pinnacle Health Cardiovascular Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn MacFarlane, LPN, CRC
Email
macfarlanedm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Hemal Gada, MD
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Loffredo
Email
kloffredo@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
John Boehmer, MD
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Bastinck
Email
Heather.Bastinck@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Nicholas Ruggiero, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Yeager
Phone
412-359-8468
Email
Matthew.YEAGER@ahn.org
First Name & Middle Initial & Last Name & Degree
Manreet Kanwar, MD
Facility Name
UPMC Heart and Vascular Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Enlow
Phone
412-647-1582
Email
enlowms@upmc.edu
First Name & Middle Initial & Last Name & Degree
Catalin Toma, MD
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori-Ann Desimone
Email
ldesimone@lifespan.org
First Name & Middle Initial & Last Name & Degree
Paul Gordon, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debi Everidge, RN, BSN
Phone
843-792-2944
Email
adamsde@musc.edu
First Name & Middle Initial & Last Name & Degree
Daniel Steinberg, MD
Facility Name
Prisma Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Adams
Email
Julia.Adams@prismahealth.org
First Name & Middle Initial & Last Name & Degree
Patrick McCann, MD
Facility Name
Tennova Healthcare-Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Polk
First Name & Middle Initial & Last Name & Degree
Malcolm T Foster, III, MD
Facility Name
Ascension Saint Thomas
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amelia Drennan
Email
amelia.drennan@ascension.org
First Name & Middle Initial & Last Name & Degree
Don Chomsky, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
87232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Bowman
Phone
615-936-0061
Email
sherry.bowman@vumc.org
First Name & Middle Initial & Last Name & Degree
Colin Barker, MD
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Carpenter, RN
Phone
512-206-3603
Email
Amanda.Carpenter2@HCAHealthcare.com
First Name & Middle Initial & Last Name & Degree
Juhana Karha, MD
Facility Name
Houston Heart
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Morrison
Phone
832-633-5463
Email
Joan.Morrison@HCAhealthcare.com
First Name & Middle Initial & Last Name & Degree
Pranav Loyalka, MD
Facility Name
Baylor College of Medicine St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Kronman-Gross
Phone
713-798-6230
Email
Rachel.kronman-gross@bcm.edu
First Name & Middle Initial & Last Name & Degree
Ajith Nair, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaShawna Green
Phone
713-441-6548
Email
lagreen2@HoustonMethodist.org
Facility Name
UT Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chandni Patel
Email
Chandni.Patel@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Marwan Jumean, MD
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Condez
Phone
806-470-0913
Email
Theresa.Condez@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Mohammad (Mac) Ansari, MD
Facility Name
Baylor Scott & White
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Terminated
Facility Name
Methodist Healthcare System, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurene Cantu, RN
Phone
210-575-7863
Email
Maurene.Cantu@HCAhealthcare.com
First Name & Middle Initial & Last Name & Degree
Jorge Alvarez, MD
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riley Hodgson
Phone
801-507-4798
Email
Riley.Hodgson@imail.org
First Name & Middle Initial & Last Name & Degree
Brian Whisenant, MD
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Bailes Bryceland, RN, CCRC
First Name & Middle Initial & Last Name & Degree
Sula Mazimba, MD
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany McMichael
Email
bymcmich@sentara.com
First Name & Middle Initial & Last Name & Degree
Amit Badiye, MD
Facility Name
CJW Chippenham Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Burton
Phone
804-852-2747
Email
Stephanie.burton@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Scott Lim, MD
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Bryant
Phone
540-853-0364
Email
cdbryant@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Jason Foerst, MD
Facility Name
Valley Health Winchester
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebekah Smith, RN, BSN
Phone
540-536-5547
Email
rsmith3@valleyhealthlink.com
First Name & Middle Initial & Last Name & Degree
Jason Call, MD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Schaeffer
Phone
206-221-9154
Email
jschaeffer@cardiology.washington.edu
First Name & Middle Initial & Last Name & Degree
Christine Chung, MD
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole McConnell
Phone
509-474-4308
Email
Nicole.McConnell@providence.org
First Name & Middle Initial & Last Name & Degree
James Mudd, MD
Facility Name
CAMC Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Han, MD
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Lobacz
Phone
414-649-3438
Email
Donald.Lobacz@aah.org
First Name & Middle Initial & Last Name & Degree
Suhail Allaqaband, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Shimada-Krouwer, RN
Email
bshikrouwer@mcw.edu
First Name & Middle Initial & Last Name & Degree
Saif Anwaruddin, MD
Facility Name
Republican Scientific and Practical Centre of Cardiology
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olesya Shatova, MD
Email
bai1982@mail.ru
First Name & Middle Initial & Last Name & Degree
Prof. Alena Kurlianskaya, MD, PhD
Facility Name
OLV Heart Centre
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy De Knijf
Phone
053/72 44 49
Email
kathy.de.knijf@olvz-aalst.be
First Name & Middle Initial & Last Name & Degree
Jozef Bartunek, MD, PhD
Facility Name
AZ Sint-Jan-Oostende AV Campus Brugge
City
Brugge
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrien Derycker
Email
Katrien.Derycker@azsintjan.be
First Name & Middle Initial & Last Name & Degree
Jan Van Der Heijden, MD, PhD
Facility Name
St. Anne's University Hospital
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ota Hlinomaz, MD
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Moučka
Phone
420 257 272 392
Email
petr.moucka@homolka.cz
First Name & Middle Initial & Last Name & Degree
Prof. Petr Neužil, MD, CSc, FESC
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cuisset, MCU-PH, MD, PhD
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Leurent, MD
Facility Name
Clinique-Pasteur
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Dumonteil, MD
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conny Feirabend
Phone
31 (0)88 320 0900
Email
c.feirabend@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Benno Rensing, MD
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Huijskens-van Herpen
Phone
06 282 879 04
Email
e.huijskens@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Nicolas Van Mieghem, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

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