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Device

AccuCinch® System for Heart Failure (CorCinch-HFrEF Trial)

N/A

Waitlist Available

Led By Ulrich Jorde, MD

Research Sponsored by Ancora Heart, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptom Status: NYHA III-IV (i.e., ambulatory)

Study patient is at least 18-years old

Must not have

Untreated clinically significant coronary artery disease (CAD) requiring revascularization

Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-day

Awards & highlights

Summary

This trial is testing a new device to treat heart failure in patients with reduced ejection fraction.

Who is the study for?

Adults with heart failure and reduced ejection fraction (HFrEF), specifically those with a left ventricular diameter ≥55 mm, ejection fraction between 20-40%, and stable on optimal heart failure therapies. Participants must have certain devices like CRT or ICD implanted for specified durations before enrollment, be able to perform diagnostic tests, follow the study schedule, and have NYHA class III-IV symptoms.

What is being tested?

The trial is testing the AccuCinch® Ventricular Restoration System in patients with HFrEF. It's an early-stage study that's not randomized but is prospective and multi-center. The goal is to see how well this system works in improving heart function by cinching the ventricle.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include complications from device implantation such as bleeding or infection at the access site, allergic reactions to materials used in the device (nitinol, polyester, polyethylene), or worsening of heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have heart issues but can still walk around.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart artery disease that hasn't been treated with surgery.

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My kidney function is severely reduced.

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I have an ongoing heart infection.

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I have had surgery or a procedure on my mitral valve.

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I have low blood pressure or need support to maintain my blood circulation.

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I have a heart condition other than dilated cardiomyopathy causing heart failure.

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My body cannot support the AccuCinch® implant due to physical limitations.

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I have a serious issue with my aortic valve or have an artificial one.

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I am currently taking high dose steroids or immunosuppressants.

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I have not had a stroke or major disability from a stroke in the last 3 months.

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I cannot take blood thinners or anti-clotting medications.

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I am not pregnant, using birth control, or breastfeeding.

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I do not have any heart surgery or procedures planned in the next 6 months.

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I cannot walk or carry out any physical activity without discomfort.

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I have severe leakage in my heart's tricuspid valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety measured by device-related or procedure-related major adverse events (MAEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: AccuCinch® Ventricular Restoration SystemExperimental Treatment1 Intervention

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ancora Heart, Inc.Lead Sponsor

8 Previous Clinical Trials

598 Total Patients Enrolled

6 Trials studying Heart Failure

574 Patients Enrolled for Heart Failure

Michael Zapien, MS, CCRAStudy DirectorAncora Heart, Inc.

3 Previous Clinical Trials

172 Total Patients Enrolled

3 Trials studying Heart Failure

172 Patients Enrolled for Heart Failure

Ulrich Jorde, MDPrincipal InvestigatorMontefiore Medical Center

3 Previous Clinical Trials

70 Total Patients Enrolled

3 Trials studying Heart Failure

70 Patients Enrolled for Heart Failure

Media Library

AccuCinch® Ventricular Restoration System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03533517 — N/A

Heart Failure Research Study Groups: AccuCinch® Ventricular Restoration System

Heart Failure Clinical Trial 2023: AccuCinch® Ventricular Restoration System Highlights & Side Effects. Trial Name: NCT03533517 — N/A

AccuCinch® Ventricular Restoration System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03533517 — N/A

~3 spots leftby Sep 2025

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