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Cardiac Support Device

CorCap CSD + Mitral Valve Repair for Heart Failure (MVR + CorCap Trial)

Phase 2

Waitlist Available

Led By Edward Raines, MD

Research Sponsored by Acorn Cardiovascular, Inc.

Eligibility Criteria Checklist

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

Must have

Dilated cardiomyopathy of either ischemic or non-ischemic origin

Adult (18 to 80 years)

Must not have

Planned cardiac surgical procedure other than MVR

Presence of arrhythmias causing hemodynamic instability, history of resuscitated sudden death without subsequent treatment with implantable defibrillator or amiodarone, or atrial fibrillation with a ventricular rate greater than 100 bpm on medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is to see if the addition of the CorCapTM CSD to mitral valve surgery can help improve heart function in patients with heart failure.

Who is the study for?

This trial is for adults aged 18-80 with heart failure due to dilated cardiomyopathy, who are on stable heart failure therapy and scheduled for mitral valve repair. They must have a left ventricular ejection fraction of ≤45%, moderate to severe mitral regurgitation, and be in NYHA Class II-IV. Exclusions include recent major cardiac events or procedures, life expectancy under one year, pregnancy, enrollment in another study affecting results, certain heart conditions or surgeries.

What is being tested?

The trial tests the effectiveness of the Acorn CorCapTM Cardiac Support Device (CSD) when placed around the heart during mitral valve surgery. The CSD aims to support the heart structure and prevent further dilation associated with worsening heart failure.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include complications from device implantation such as infection or reaction to materials, issues related to extracorporeal circulation used during surgery, and general surgical risks like bleeding or adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

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

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I have a heart condition where my heart's main pumping chamber is enlarged.

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I am between 18 and 80 years old.

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My heart's pumping ability is reduced (LVEF ≤ 45%).

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My heart condition limits my physical activity.

Exclusion Criteria

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

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I am scheduled for a heart surgery that is not mitral valve replacement.

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I have heart rhythm problems that affect my blood flow.

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I had a heart procedure within the last 3 months.

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I have a thickened heart muscle that obstructs blood flow.

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My heart is too large for the CorCap CSD device.

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I have heart adhesions that may prevent complete access to my heart.

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I currently have an infection.

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I have late-stage heart failure and am considered high-risk for surgery.

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I have a functioning coronary artery bypass graft.

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I have a health condition that may shorten my life to under a year.

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I have not had a heart attack, unstable angina, stroke, or mini-stroke in the last 3 months.

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I am a candidate for surgery to improve blood flow, as confirmed by an angiogram.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acorn Cardiovascular, Inc.Lead Sponsor

Edward Raines, MDPrincipal InvestigatorBryanLGH Medical Center

Michael A Acker, MDPrincipal InvestigatorHospital of the University of Pennsylvania, Cardiovascular Medicine; Penn-Presbyterian Medical Center

Media Library

Acorn CorCap Cardiac Support Device (Cardiac Support Device) Clinical Trial Eligibility Overview. Trial Name: NCT00630266 — Phase 2

Heart Failure Clinical Trial 2023: Acorn CorCap Cardiac Support Device Highlights & Side Effects. Trial Name: NCT00630266 — Phase 2

Acorn CorCap Cardiac Support Device (Cardiac Support Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00630266 — Phase 2

~3 spots leftby Sep 2025

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