Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-31 @ 2:53 AM
Study NCT ID:
NCT04331769
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2020-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Sponsor:
Ancora Heart, Inc.
Organization:
Study Overview
Official Title:
Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
Detailed Description:
The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.
Subjects will be randomized in a 1:1 ratio:
1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n\~200)
2. Control group: Guideline-directed medical therapy (GDMT) (n\~200)
Subjects will be randomized in a 1:1 ratio:
1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n\~200)
2. Control group: Guideline-directed medical therapy (GDMT) (n\~200)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: