Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (CorCinch-HFrEF)
Primary Purpose
Heart Failure, Cardiomyopathy, Dilated
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AccuCinch® Ventricular Restoration
Sponsored by
About this trial
This is an interventional device feasibility trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Study patient is at least 18-years old
- Ejection Fraction: ≥20 and ≤40%
- LV end-diastolic diameter ≥55 mm
- Symptom Status: NYHA III-IV (i.e., ambulatory)
- Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses.
- Patients with left bundle branch block pattern and QRS duration >150ms are required to have a CRT device for at least 3 months
- Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
- Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
Exclusion Criteria:
- Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
- Mitral regurgitation grade 3 (moderate-severe) or more
- Prior surgical, transcatheter, or percutaneous mitral valve intervention
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization
- Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
- NYHA class IV (i.e., non-ambulatory)
- Significant RV dysfunction (TAPSE < 14)
- Severe tricuspid regurgitation
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)
- Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
- Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
- Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
- Active bacterial endocarditis
- History of any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke
- Subjects in whom anticoagulation or 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.
- Life expectancy < 1 year due to non-cardiac conditions
- Currently participating in another interventional investigational study
- Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
- Subjects on high dose steroids or immunosuppressant therapy
- Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating
Sites / Locations
- University of California, San Francisco
- Emory University Hospital Midtown
- University of Louisville
- Cardiovascular Institute of the South
- Minneapolis Heart Foundation Institute
- Nebraska Heart Institute / Nebraska Heart Hospital
- Hackensack University Medical Center
- Montefiore Medical Center
- Mt. Sinai
- Columbia University Medical Center/NYPH
- The Christ Hospital
- Pinnacle Health Cardiovascular Institute
- Penn State Health Milton S. Hershey Medical Center
- University of Pennsylvania
- Baylor College of Medicine St. Luke's Medical Center
- Intermountain Medical Center
- University of Virginia School of Medicine
- Carilion Roanoke Memorial
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AccuCinch® Ventricular Restoration System
Arm Description
Outcomes
Primary Outcome Measures
Safety measured by device-related or procedure-related major adverse events (MAEs)
Device-related or procedure-related major adverse events (MAEs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03533517
Brief Title
Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
Acronym
CorCinch-HFrEF
Official Title
An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
July 31, 2026 (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
No
5. Study Description
Brief Summary
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
Detailed Description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiomyopathy, Dilated
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AccuCinch® Ventricular Restoration System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AccuCinch® Ventricular Restoration
Intervention Description
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
Primary Outcome Measure Information:
Title
Safety measured by device-related or procedure-related major adverse events (MAEs)
Description
Device-related or procedure-related major adverse events (MAEs)
Time Frame
30-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Study patient is at least 18-years old
Ejection Fraction: ≥20 and ≤40%
LV end-diastolic diameter ≥55 mm
Symptom Status: NYHA III-IV (i.e., ambulatory)
Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses.
Patients with left bundle branch block pattern and QRS duration >150ms are required to have a CRT device for at least 3 months
Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
Exclusion Criteria:
Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
Mitral regurgitation grade 3 (moderate-severe) or more
Prior surgical, transcatheter, or percutaneous mitral valve intervention
Untreated clinically significant coronary artery disease (CAD) requiring revascularization
Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
NYHA class IV (i.e., non-ambulatory)
Significant RV dysfunction (TAPSE < 14)
Severe tricuspid regurgitation
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)
Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
Active bacterial endocarditis
History of any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke
Subjects in whom anticoagulation or 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.
Life expectancy < 1 year due to non-cardiac conditions
Currently participating in another interventional investigational study
Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
Subjects on high dose steroids or immunosuppressant therapy
Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zapien, MS, CCRA
Organizational Affiliation
Ancora Heart, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ulrich Jorde, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azeem Latib, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Minneapolis Heart Foundation Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Nebraska Heart Institute / Nebraska Heart Hospital
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77020
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Carilion Roanoke Memorial
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
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