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Assessment of CCM in HF With Higher Ejection Fraction (AIM HIGHer)

Primary Purpose

Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
OPTIMIZER™ Smart Mini System
Sponsored by
Impulse Dynamics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring HFpEF, Heart failure, CCM, CCM therapy, cardiac contractility modulation, symptomatic heart failure, left ventricular ejection fraction, LVEF, Optimizer, Optimizer Smart Mini, Quality of Life

Eligibility Criteria

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

Inclusion Criteria:

  1. Signed and dated informed consent form;
  2. Male or non-pregnant female, 21 years or older;
  3. Diagnosed with symptomatic heart failure;
  4. LVEF ≥40 and ≤60% (as assessed by echo core lab);
  5. Heart failure hospitalization within 12 months prior to study consent OR Urgent heart failure visit requiring IV therapy during the 6 months prior to study consent;
  6. Elevated NT-proBNP levels, >200 pg/ml for subjects without atrial tachyarrhythmia (AT) or >600 pg/ml for subjects in AT OR Elevated BNP levels, >75 pg/ml for subjects without AT or >225 pg/ml for subjects in AT;

6) Subjects must be on a stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy.

Exclusion Criteria:

  1. Resting heart rate <50 or >110 bpm;
  2. Resting systolic blood pressure <100 or ≥160 mmHg;
  3. BMI greater than 40
  4. Any moderate or severe valvular stenotic disease or any severe valvular regurgitation;
  5. Mechanical tricuspid valve;
  6. Complex congenital heart disease;
  7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
  8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
  9. A KCCQ CCS score higher than 85;
  10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
  11. Unstable angina pectoris within 30 days prior to study consent;
  12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
  13. Receiving cardiac resynchronization therapy (CRT);
  14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
  15. Myocardial infarction within 90 days prior to study consent;
  16. Prior heart transplant or ventricular assist device;
  17. Planning to become pregnant during the study;
  18. Dialysis (permanent) or GFR <20 ml/min/1.73m2;
  19. Participating in another investigational study;
  20. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
  21. Expected lifespan of less than 18 months from time of study consent;

Sites / Locations

  • Grandview Medical Group Research, LLCRecruiting
  • The University of Alabama at BirminghamRecruiting
  • CardioVascular Associates of MesaRecruiting
  • Chan Heart Rhythm InstituteRecruiting
  • Southwest Cardiovascular AssociatesRecruiting
  • Banner Health- PhoenixRecruiting
  • Arizona Heart RhythmRecruiting
  • Cardiovascular Consultants, LtdRecruiting
  • HonorHealthRecruiting
  • Pima Heart and VascularRecruiting
  • John Muir HealthRecruiting
  • Northbay Heart and VascularRecruiting
  • USC Keck School of MedicineRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Valley Clinical Trials- Foothill CardiologyRecruiting
  • Valley Clinical Trials- NorthridgeRecruiting
  • Sequoia HospitalRecruiting
  • University of California Davis HealthRecruiting
  • University of California, San FranciscoRecruiting
  • Nuvance HealthRecruiting
  • HCA Florida JFK HospitalRecruiting
  • Nouvelle Clinical Research LLCRecruiting
  • Holy Cross HospitalRecruiting
  • Broward HealthRecruiting
  • Memorial Healthcare SystemRecruiting
  • Baptist Health South FloridaRecruiting
  • NCA Research Institute - FloridaRecruiting
  • AdventHealth OrlandoRecruiting
  • Revival Clinical ResearchRecruiting
  • Tallahassee Research InstituteRecruiting
  • Cleveland Clinic Foundation - Florida Weston HospitalRecruiting
  • Piedmont HealthcareRecruiting
  • WellStar Health System, IncRecruiting
  • Franciscan Health IndianapolisRecruiting
  • Ascension Medical Group St. VincentRecruiting
  • MercyOne Iowa HeartRecruiting
  • University of Kansas Medical CenterRecruiting
  • Kansas City Cardiac Arrhythmia Research LLCRecruiting
  • Baptist Health LexingtonRecruiting
  • University of Kentucky Research FoundationRecruiting
  • Ochsner Clinic FoundationRecruiting
  • Massachusetts General HospitalRecruiting
  • Ascension St. JohnRecruiting
  • Ascension Providence HospitalRecruiting
  • Trinity health- Michigan HeartRecruiting
  • Minneapolis Heart Institute at Abbott Northwestern HospitalRecruiting
  • North Mississippi Medical CenterRecruiting
  • St. Louis Heart and VascularRecruiting
  • St. Luke's HospitalRecruiting
  • St. Lukes Hospital Kansas City (Mid America Heart Institute)Recruiting
  • Bryan HeartRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Catholic Medical CenterRecruiting
  • Our Lady of LourdesRecruiting
  • Hackensack University Medical CenterRecruiting
  • Jersey Shore University Medical CenterRecruiting
  • Cooper Hospital- Cardiovascular Associates of Delaware ValleyRecruiting
  • Atlantic Health System- Morristown Medical CenterRecruiting
  • Rutgers New Jersey Medical SchoolRecruiting
  • Weill Cornell MedicineRecruiting
  • Sanger Heart and VascularRecruiting
  • TriHealth BethesdaRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Cleveland Clinic FoundationRecruiting
  • Ohio State University Wexner Medical CenterRecruiting
  • OhioHealth Research InstituteRecruiting
  • Mercy Health- St. Vincent Medical Center LLCRecruiting
  • Oklahoma Heart InstituteRecruiting
  • Providence Heart & VascularRecruiting
  • Bryn Mawr Medical Specialists AssociationRecruiting
  • UPMC Pinnacle HarrisburgRecruiting
  • Penn State Hershey Medical CityRecruiting
  • Lancaster General Hospital
  • Penn Presbyterian Medical CenterRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • Temple University HospitalRecruiting
  • Allegheny General HospitalRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Tower Health Reading HospitalRecruiting
  • Prisma Health UpstateRecruiting
  • The Stern Cardiovascular FoundationRecruiting
  • Texas Cardiac Arrhythmia Research FoundationRecruiting
  • Ascension SetonRecruiting
  • Austin HeartRecruiting
  • Baylor Scott and White Research InstituteRecruiting
  • HCA Medical City DallasRecruiting
  • Baylor Scott White- All Saints- Fort WorthRecruiting
  • Medical City Fort Worth HospitalRecruiting
  • Baylor College of MedicineRecruiting
  • Houston MethodistRecruiting
  • Memorial Hermann Texas Medical CenterRecruiting
  • Heart Rhythm SpecialistsRecruiting
  • Baylor Scott and White- The Heart Hospital- PlanoRecruiting
  • Baylor Scott and White Research Institute - Round RockRecruiting
  • Methodist HospitalRecruiting
  • Peace HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CCM Group (CCM ON)

Sham Group (CCM OFF)

Arm Description

CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.

CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration.

Outcomes

Primary Outcome Measures

Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months.
Demonstrate that CCM therapy improves functional capacity in subjects with symptomatic heart failure with LVEF ≥40% and ≤60%. Compare the changes in functional capacity, as measured by the 6-minute walk distance (6MWD), from baseline to 6-months following the randomization date between the two study groups.
Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS).
Demonstrate that CCM therapy improves health status in subjects with symptomatic heart failure with LVEF ≥40% and ≤60%. Compare the changes in health status, as measured by the KCCQ CSS, from baseline to 6-months following the randomization date between the two study groups.
Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant
Compare the composite incidence of Optimizer device-related and procedure-related SAEs (complications) for available data collected from implant to 12 months after the Optimizer implantation procedure to a performance goal of 75% free of complications.
Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS).
Demonstrate that CCM therapy improves a composite endpoint of cardiovascular mortality at 18-months, heart failure hospitalizations at 18-months, urgent heart failure visits requiring IV diuretics at 18-months and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) at 12-months. Comparison of a hierarchical composite endpoint between the two study groups will be based on the Finkelstein-Schoenfeld global rank method.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2021
Last Updated
October 19, 2023
Sponsor
Impulse Dynamics
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1. Study Identification

Unique Protocol Identification Number
NCT05064709
Brief Title
Assessment of CCM in HF With Higher Ejection Fraction
Acronym
AIM HIGHer
Official Title
Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impulse Dynamics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤60%.
Detailed Description
The AIM HIGHer Clinical Trial is a prospective, multi-center, randomized, quadruple-blind, sham-controlled, two-part embedded trial of the safety and efficacy of CCM therapy delivered via the OPTIMIZER Smart Mini System in subjects with heart failure and an LVEF ≥40% and ≤60%. Subjects will be enrolled at approximately 150 sites in the US and 75 sites OUS. All subjects will undergo screening and baseline testing; all eligible subjects will be implanted with the Optimizer System. Subjects will be randomized in a 2:1 ratio to either CCM ON (CCM group) or to CCM OFF (Sham group). The trial will be blinded to the treatment assignment of the device for 18-months. Subjects in the Sham group will have CCM turned ON after completion of the 18-month study visit. Subjects enrolled during Part I (450 subjects) of the trial will continue follow-up through the end of Part II (up to an additional 1,050) and contribute data to both parts of the trial. Each part of the trial is distinguished by a separate scientific purpose. The specific purpose of each part is: Part I - Establish safety and effectiveness based on functional capacity and health status. Part II - Establish safety and effectiveness based on clinical outcome data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection Fraction, Diastolic Heart Failure
Keywords
HFpEF, Heart failure, CCM, CCM therapy, cardiac contractility modulation, symptomatic heart failure, left ventricular ejection fraction, LVEF, Optimizer, Optimizer Smart Mini, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, multi-national, randomized, quadruple-blind, sham controlled, 2-part, embedded IDE clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
In addition to the subject, the entire site research team, the implanting physician, the Clinical Events Committee (CEC), and the clinical study monitors will all be blinded to the treatment assignment. Site research staff and Impulse Dynamics monitoring personnel will not have viewing rights to the randomization assignment.
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCM Group (CCM ON)
Arm Type
Experimental
Arm Description
CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.
Arm Title
Sham Group (CCM OFF)
Arm Type
Sham Comparator
Arm Description
CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration.
Intervention Type
Device
Intervention Name(s)
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
Other Intervention Name(s)
CCM Group (CCM ON)
Intervention Description
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.
Intervention Type
Device
Intervention Name(s)
OPTIMIZER™ Smart Mini System
Other Intervention Name(s)
Sham Group (CCM OFF)
Intervention Description
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.
Primary Outcome Measure Information:
Title
Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months.
Description
Demonstrate that CCM therapy improves functional capacity in subjects with symptomatic heart failure with LVEF ≥40% and ≤60%. Compare the changes in functional capacity, as measured by the 6-minute walk distance (6MWD), from baseline to 6-months following the randomization date between the two study groups.
Time Frame
6 months
Title
Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS).
Description
Demonstrate that CCM therapy improves health status in subjects with symptomatic heart failure with LVEF ≥40% and ≤60%. Compare the changes in health status, as measured by the KCCQ CSS, from baseline to 6-months following the randomization date between the two study groups.
Time Frame
6 months
Title
Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant
Description
Compare the composite incidence of Optimizer device-related and procedure-related SAEs (complications) for available data collected from implant to 12 months after the Optimizer implantation procedure to a performance goal of 75% free of complications.
Time Frame
12 months
Title
Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS).
Description
Demonstrate that CCM therapy improves a composite endpoint of cardiovascular mortality at 18-months, heart failure hospitalizations at 18-months, urgent heart failure visits requiring IV diuretics at 18-months and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) at 12-months. Comparison of a hierarchical composite endpoint between the two study groups will be based on the Finkelstein-Schoenfeld global rank method.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated informed consent form; Male or non-pregnant female, 18 years or older; Diagnosed with symptomatic heart failure; LVEF ≥40 and ≤60% (as assessed by echo core lab); A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, AND elevated BMI-adjusted natriuretic peptide values (Refer to Table A in Section 9.2.6) OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table B in Section 9.2.6) Subjects must be on stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy/intolerance. Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event. Exclusion Criteria: Resting ventricular rate <50 or >110 bpm; Resting systolic blood pressure <100 or ≥160 mmHg; BMI greater than 46 Any severe valvular stenotic disease or any severe valvular regurgitation; Mechanical tricuspid valve; Complex congenital heart disease; Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance; Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT; A KCCQ CCS score higher than 85; Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy; Unstable angina pectoris within 30 days prior to study consent; Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting; Receiving cardiac resynchronization therapy (CRT); Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; Myocardial infarction within 90 days prior to study consent; Prior heart transplant or ventricular assist device; Planning to become pregnant during the study; Dialysis (permanent) or GFR <20 ml/min/1.73m2; Participating in another investigational study; Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent; Expected lifespan of less than 18 months from time of study consent;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Fernanda Villarreal, MD
Phone
8453592389
Email
aimhigher@impulsedynamics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javed Butler, MD, MPH, MBA
Organizational Affiliation
Baylor Scott and White Research Institute, Dallas, Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oussama Wazni, MD, MBA
Organizational Affiliation
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
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
Lauren Bryant
Phone
205-971-7553
Email
lauren.bryant@grandviewhealth.com
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marva Robinson
Email
Marva_Robinson@trihealth.com
Facility Name
CardioVascular Associates of Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Gitkin
Phone
480-641-5400
Ext
2107
Email
agitkin@cvam.com
Facility Name
Chan Heart Rhythm Institute
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Rivera
Email
olivia@chanheartrhythm.com
Facility Name
Southwest Cardiovascular Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Helgeson
Phone
480-945-4343
Ext
244
Email
khelgeson@swcva.com
Facility Name
Banner Health- Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Freeman
Email
mathew.freeman@bannerhealth.com
First Name & Middle Initial & Last Name & Degree
Raeven Maxwell
Email
raeven.maxwell@bannerhealth.com
Facility Name
Arizona Heart Rhythm
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
Brandon Buscaglia
Email
bbuscaglia@azheartrhythm.com
Facility Name
Cardiovascular Consultants, Ltd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Foughi
Email
hfoughi@insightmedr.com
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Hultman
Email
rhultman@honorhealth.com
Facility Name
Pima Heart and Vascular
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
Monica Varela
Phone
520-329-4139
Email
monica.varela@pimaheartandvascular.com
Facility Name
John Muir Health
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Trachuk
Email
rita.trachuk@johnmuirhealth.com
Facility Name
Northbay Heart and Vascular
City
Fairfield
State/Province
California
ZIP/Postal Code
94533
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belmary Astacio
Email
bastacio@northbay.org
Facility Name
USC Keck School of Medicine
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
Email
melissa.ramos@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Silvia Perez
Email
silvia.perez@med.usc.edu
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Stankovic
Email
goran.stankovic@cshs.org
Facility Name
Valley Clinical Trials- Foothill Cardiology
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hydee Gutierrez
Email
haydee@valleyclinicaltrials.com
Facility Name
Valley Clinical Trials- Northridge
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haydee Gutierrez
Email
haydee@valleyclinicaltrials.com
Facility Name
Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juanita Fujii
Email
juanita.fujii@commonspirit.org
Facility Name
University of California Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chinh Thai
Email
cqthai@ucdavis.edu
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
Jessica Nguyen
Phone
415-502-6180
Email
jessica.nguyen@ucsf.edu
Facility Name
Nuvance Health
City
Wilton
State/Province
Connecticut
ZIP/Postal Code
06897
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tricia Landi
Email
tricia.landi@nuvancehealth.org
Facility Name
HCA Florida JFK Hospital
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
Elizabeth Diebel
Email
Elizabeth.Diebel@hcahealthcare.com
Facility Name
Nouvelle Clinical Research LLC
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Cabrera
Email
acabrera@nouvelleclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Nilda Cespedes
Email
ncespedes@nouvelleclinicalresearch.com
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Lepurage
Phone
954-229-8551
Email
christine.lepurage@holy-cross.com
First Name & Middle Initial & Last Name & Degree
Joseph Kurian
Phone
9542298571
Email
joseph.kurian001@holy-cross.com
Facility Name
Broward Health
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Hudson
Email
lhudson@browardhealth.org
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nithya Sundararam
Phone
954-265-1846
Email
nsundararaman@mhs.net
Facility Name
Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jetsenea Coto
Phone
786-596-2421
Email
jetseneac@baptisthealth.net
Facility Name
NCA Research Institute - Florida
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Martin
Email
lhmartin427@gmail.com
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chanti Garvey
Email
chantie.garvey@adventhealth.com
Facility Name
Revival Clinical Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseniesse Figueroa
Email
jfigueroa@revivalclinical.com
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Gerald
Email
katherine.gearld@tmh.org
Facility Name
Cleveland Clinic Foundation - Florida Weston Hospital
City
Weston
State/Province
Florida
ZIP/Postal Code
33326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Mejia Gomez
Email
MEJIAGM@ccf.org
Facility Name
Piedmont Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Picardi
Email
kristina.picardi@piedmont.org
Facility Name
WellStar Health System, Inc
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Drury
Email
jessica.drury@wellstar.org
First Name & Middle Initial & Last Name & Degree
Denise Grove
Email
dgrove@wellspan.org
Facility Name
Franciscan Health Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Alford
Email
stephanie.alford@franciscanalliance.org
Facility Name
Ascension Medical Group St. Vincent
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Rotondo
Email
sabrina.rotondo@ascension.org
Facility Name
MercyOne Iowa Heart
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cayla Garner
Email
cayla.barnhart@commonspirit.org
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quratulain (Annie) Mushtaq
Phone
913-945-6488
Email
qmushtaq@kumc.edu
Facility Name
Kansas City Cardiac Arrhythmia Research LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donita Atkins
Email
donita.atkins@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Jenny Bush
Email
jennifer.bush2@hcahealthcare.com
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristie Schneider
Phone
859-260-6429
Email
kschneid@bhsi.com
Facility Name
University of Kentucky Research Foundation
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Smith
Email
Ronald.t.smith@uky.edu
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Lunn
Email
mlunn@ochsner.org
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
Chinemerem Nwokemodo-Ihejirika
Email
cnwokemodo-ihejirika@mgh.harvard.edu
Facility Name
Ascension St. John
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Bess
Email
renee.bess@ascension.org
Facility Name
Ascension Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candice Edillo
Email
candice.edillo@ascension.org
Facility Name
Trinity health- Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Autumn Howe
Email
ahowe@michiganheart.com
Facility Name
Minneapolis Heart Institute at Abbott Northwestern Hospital
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
Jessica Whelan
Phone
612-863-1661
Email
jessica.whelan@allina.com
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Ray
Email
yray@nmhs.net
Facility Name
St. Louis Heart and Vascular
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paige Brown
Phone
314-741-0911
Ext
4044
Email
pbrown@slhv.com
Facility Name
St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Lesko
Email
Janet.Lesko@stlukes-stl.com
Facility Name
St. Lukes Hospital Kansas City (Mid America Heart Institute)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Huffman
Email
ahuffman@saint-lukes.org
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicci Thompson
Email
nicci.thompson@bryanheart.com
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Hoover-Shultz
Email
b.hooverschultz@unmc.edu
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Moritz
Email
lori.moritz@cmc-nh.org
Facility Name
Our Lady of Lourdes
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Brown
Phone
856-355-1226
Email
mbrown3@virtua.org
Facility Name
Hackensack University Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Arkelian
Phone
551-996-5722
Email
patricia.arakelian@hmhn.org
Facility Name
Jersey Shore University Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Argenzio
Email
lynda.argenzio@hmhn.org
Facility Name
Cooper Hospital- Cardiovascular Associates of Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Siderio
Phone
856-582-2000
Ext
5207
Email
esiderio@hearthousenj.com
Facility Name
Atlantic Health System- 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
Facility Name
Rutgers New Jersey Medical School
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Lau
Email
Jll303@njms.rutgers.edu
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Reynolds
Email
dtr2001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Penn Collins
Phone
2127464857
Email
gpc4001@med.cornell.edu
Facility Name
Sanger Heart and Vascular
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Dellinger
Email
connie.dellinger@atriumhealth.org
Facility Name
TriHealth Bethesda
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Freel
Email
laurie_freel@trihealth.com
First Name & Middle Initial & Last Name & Degree
Marva Robinson
Email
marva_robinson@trihealth.com
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy McKnight
Email
amy.mcknight@uhhospitals.org
Facility Name
Cleveland Clinic Foundation
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
Barbara Gus
Email
gusb@ccf.org
Facility Name
Ohio State University Wexner Medical Center
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
Maeve McLoughlin
Phone
614-292-4084
Email
maeve.mcloughlin@osumc.edu
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem (Mimi) Bekheet
Email
reem.bekheet@ohiohealth.com
Facility Name
Mercy Health- St. Vincent Medical Center LLC
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Hickam
Email
michelle_hickam@mercy.com
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
Colene Holland son
Email
colene.hollandson@oklahomaheart.com
First Name & Middle Initial & Last Name & Degree
Miriam Brooks
Email
miriam.brooks@oklahomaheart.com
Facility Name
Providence Heart & Vascular
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
Facility Name
Bryn Mawr Medical Specialists Association
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgan Battiste
Email
mbattiste@bmmsa.com
Facility Name
UPMC Pinnacle Harrisburg
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Meise
Phone
717-920-4400
Ext
4280
Email
meisegc@upmc.edu
Facility Name
Penn State Hershey Medical City
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
Lisa Fox
Email
lfox5@pennstatehealth.psu.edu
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Withdrawn
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-6061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Shoemaker
Email
katie.shoemaker@pennmedicine.upenn.edu
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Marvel
Email
emily.marvel@pennmedicine.upenn.edu
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kriti Rawat
Email
kriti.rawat@temple.edu
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
Kelly Kuniak
Email
Kelly.kuniak4@ahn.org
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Traci McGaha
Email
mcgahatl4@upmc.edu
Facility Name
Tower Health Reading Hospital
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee McLin
Email
renee.mclin@towerhealth.org
Facility Name
Prisma Health Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Rebain
Phone
864-455-4438
Email
rebecca.rebain@prismahealth.org
Facility Name
The Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Page
Email
kristen.page@sterncardio.com
First Name & Middle Initial & Last Name & Degree
Kari Fondren
Email
kari.fondren@sterncardio.com
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deb Cardinal
Phone
512-522-9410
Email
dscardinal@austinheartbeat.com
Facility Name
Ascension Seton
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Benedict
Email
sarah.benedict@ascension.org
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
Mary Fraser
Email
Mary.Fraser@hcahealthcare.com
Facility Name
Baylor Scott and White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tein Luu
Phone
214-865-1685
Ext
481685
Email
tein.luu@bswhealth.org
Facility Name
HCA Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corryn Weatherred
Email
corryn.weatherred@hcahealthcare.com
Facility Name
Baylor Scott White- All Saints- Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicity Vaughan
Phone
817-922-2575
Email
felicity.vaughan@bswhealth.org
Facility Name
Medical City Fort Worth Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Blades
Email
Jessica.Blades@HCAhealthcare.com
First Name & Middle Initial & Last Name & Degree
Brenda Tapia
Email
Brenda.Tapia@HCAhealthcare.com
Facility Name
Baylor College of Medicine
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
Stephen Harold
Email
harold@bcm.edu
Facility Name
Houston Methodist
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
Deborah Barr
Email
ddbarr@houstonmethodist.org
Facility Name
Memorial Hermann Texas Medical Center
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
Lawana Self
Email
Lawana.self@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Isabella Lefebvre
Email
Isabella.n.candelaria@uth.tmc.edu
Facility Name
Heart Rhythm Specialists
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Buchanan
Email
research@hrsmedical.com
Facility Name
Baylor Scott and White- The Heart Hospital- Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaTisha Brice
Email
latisha.brice@bswhealth.org
Facility Name
Baylor Scott and White Research Institute - Round Rock
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Lyman
Email
catherine.lyman@bswhealth.org
Facility Name
Methodist Hospital
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
Paige Castaneda
Email
paige.castaneda@hcahealthcare.com
Facility Name
Peace Health
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Fitch
Email
nfitch@peacehealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29754812
Citation
Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10. Erratum In: JACC Heart Fail. 2023 Jan;11(1):132.
Results Reference
background
PubMed Identifier
32264716
Citation
Wiegn P, Chan R, Jost C, Saville BR, Parise H, Prutchi D, Carson PE, Stagg A, Goldsmith RL, Burkhoff D. Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study. Circ Heart Fail. 2020 Apr;13(4):e006512. doi: 10.1161/CIRCHEARTFAILURE.119.006512. Epub 2020 Apr 8.
Results Reference
background
PubMed Identifier
33274601
Citation
Tschope C, Butler J, Farmakis D, Morley D, Rao I, Filippatos G. Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function. ESC Heart Fail. 2020 Dec;7(6):3531-3535. doi: 10.1002/ehf2.13126. Epub 2020 Dec 3.
Results Reference
background
PubMed Identifier
26638055
Citation
Tschope C, Van Linthout S, Spillmann F, Klein O, Biewener S, Remppis A, Gutterman D, Linke WA, Pieske B, Hamdani N, Roser M. Cardiac contractility modulation signals improve exercise intolerance and maladaptive regulation of cardiac key proteins for systolic and diastolic function in HFpEF. Int J Cardiol. 2016 Jan 15;203:1061-6. doi: 10.1016/j.ijcard.2015.10.208. Epub 2015 Oct 27. No abstract available.
Results Reference
background

Learn more about this trial

Assessment of CCM in HF With Higher Ejection Fraction

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