CorCinch-HFrEF: Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: AccuCinch® Ventricular Restoration System
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Device: AccuCinch® Ventricular Restoration
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
|
Outcome Measures
Primary Outcome Measures
- Safety measured by device-related or procedure-related major adverse events (MAEs) [30-day]
Device-related or procedure-related major adverse events (MAEs)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Study patient is at least 18-years old
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Ejection Fraction: ≥20 and ≤40%
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LV end-diastolic diameter ≥55 mm
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Symptom Status: NYHA III-IV (i.e., ambulatory)
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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.
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Patients with left bundle branch block pattern and QRS duration >150ms are required to have a CRT device for at least 3 months
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Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
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Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
Exclusion Criteria:
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Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
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Mitral regurgitation grade 3 (moderate-severe) or more
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Prior surgical, transcatheter, or percutaneous mitral valve intervention
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Untreated clinically significant coronary artery disease (CAD) requiring revascularization
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Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
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Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
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NYHA class IV (i.e., non-ambulatory)
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Significant RV dysfunction (TAPSE < 14)
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Severe tricuspid regurgitation
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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
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Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)
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Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
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Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
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Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
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Active bacterial endocarditis
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History of any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke
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Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
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Known allergy to nitinol, polyester, or polyethylene
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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.
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Life expectancy < 1 year due to non-cardiac conditions
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Currently participating in another interventional investigational study
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Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
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Subjects on high dose steroids or immunosuppressant therapy
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Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
2 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
3 | Piedmont Heart Institute | Atlanta | Georgia | United States | 30309 |
4 | University of Louisville | Louisville | Kentucky | United States | 40202 |
5 | Cardiovascular Institute of the South | Houma | Louisiana | United States | 70360 |
6 | Minneapolis Heart Foundation Institute | Minneapolis | Minnesota | United States | 55407 |
7 | Nebraska Heart Institute / Nebraska Heart Hospital | Lincoln | Nebraska | United States | 68526 |
8 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
9 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
10 | Mt. Sinai | New York | New York | United States | 10029 |
11 | Columbia University Medical Center/NYPH | New York | New York | United States | 10032 |
12 | The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
13 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
14 | Pinnacle Health Cardiovascular Institute | Harrisburg | Pennsylvania | United States | 17101 |
15 | Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
16 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
17 | Austin Heart | Austin | Texas | United States | 78756 |
18 | Baylor College of Medicine St. Luke's Medical Center | Houston | Texas | United States | 77020 |
19 | Intermountain Medical Center | Salt Lake City | Utah | United States | 84109 |
20 | University of Virginia School of Medicine | Charlottesville | Virginia | United States | 22908 |
21 | Carilion Roanoke Memorial | Roanoke | Virginia | United States | 24014 |
22 | University of Washington Medicine | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- Ancora Heart, Inc.
Investigators
- Study Director: Michael Zapien, MS, CCRA, Ancora Heart, Inc.
- Principal Investigator: Ulrich Jorde, MD, Montefiore Medical Center
- Principal Investigator: Azeem Latib, MD, Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5017