Active, not recruiting
Not applicable
Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
Condition(s) studied
Heart FailureCardiomyopathy, Dilated
Investigational drug(s) / intervention(s)
AccuCinch® Ventricular Restoration
AccuCinch® Ventricular Restoration: AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
Study 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).
Eligibility
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
Primary outcome measure(s)
- Safety measured by device-related or procedure-related major adverse events (MAEs) — 30-day
Device-related or procedure-related major adverse events (MAEs)
Trial sites (18)
| Facility | City | Region | Status |
| University of California, San Francisco |
San Francisco |
California |
|
| Emory University Hospital Midtown |
Atlanta |
Georgia |
|
| University of Louisville |
Louisville |
Kentucky |
|
| Cardiovascular Institute of the South |
Houma |
Louisiana |
|
| Minneapolis Heart Foundation Institute |
Minneapolis |
Minnesota |
|
| Nebraska Heart Institute / Nebraska Heart Hospital |
Lincoln |
Nebraska |
|
| Hackensack University Medical Center |
Hackensack |
New Jersey |
|
| Mt. Sinai |
New York |
New York |
|
| Columbia University Medical Center/NYPH |
New York |
New York |
|
| Montefiore Medical Center |
The Bronx |
New York |
|
| The Christ Hospital |
Cincinnati |
Ohio |
|
| Pinnacle Health Cardiovascular Institute |
Harrisburg |
Pennsylvania |
|
| Penn State Health Milton S. Hershey Medical Center |
Hershey |
Pennsylvania |
|
| University of Pennsylvania |
Philadelphia |
Pennsylvania |
|
| Baylor College of Medicine St. Luke's Medical Center |
Houston |
Texas |
|
| Intermountain Medical Center |
Salt Lake City |
Utah |
|
| University of Virginia School of Medicine |
Charlottesville |
Virginia |
|
| Carilion Roanoke Memorial |
Roanoke |
Virginia |
|
Other trials for the same condition