Trials / Active Not Recruiting
Active Not RecruitingNCT03533517
Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Ancora Heart, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AccuCinch® Ventricular Restoration | AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF) |
Timeline
- Start date
- 2018-08-23
- Primary completion
- 2021-03-26
- Completion
- 2026-02-28
- First posted
- 2018-05-23
- Last updated
- 2025-01-30
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03533517. Inclusion in this directory is not an endorsement.