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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

MVR + CorCap Trial 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.Check my eligibility

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.See study design

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.

MVR + CorCap Trial 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.

MVR + CorCap Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in maximal exercise tolerance evaluated using cardiopulmonary exercise (CPX) testing (peak VO2 exercise test)

Change in patient functional status as evaluated using the Minnesota Living with Heart Failure questionnaire

Change in sub-maximal exercise tolerance as evaluated using the Six Minute Walk test.

+2 more

Secondary outcome measures

Change in patient functional status as evaluated using the Minnesota Living with Heart Failure Questionnaire

Rate of death and SAEs overall and for each specific type of event

0 / 4Eligibility 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this treatment been granted approval by the Federal Drug Administration?

"Our team at Power gave this treatment a safety rating of 2, since the Phase 2 trial only provides evidence for its security and not efficacy."

Answered by AI

Who has the opportunity to sign up for this investigation?

"This clinical trial seeks 50 individuals aged 18 to 80 with heart failure. To be eligible for participation, applicants must meet the following criteria: Angiotensin-converting enzyme inhibitors (ACE) or alternate if ACE not tolerated for a period of no less than 1 month prior to enrollment; Treatment with beta-blockers unless deemed intolerant by medical professionals and taken consistently over 3 months before enrolment time; Dilated cardiomyopathy originating from ischemic or non-ischemic sources; Cardiac medications remaining unchanged during the span of one complete month except diuretic adjustments when necessary; Mitral regurgitation greater than"

Answered by AI

Are there opportunities for participation in this trial presently available?

"This medical trial, which first appeared on the clinicaltrials.gov database in 2008 and was last edited in 2009, is not currently seeking participants. Nonetheless, there are 700 other studies that remain actively recruiting patients today."

Answered by AI

Is this research endeavor open to participants who are octogenarians?

"To be eligible for this scientific research, participants must meet the age requirements of 18-80. For individuals younger than 18 and adults over 65, there are 22 studies and 690 studies respectively conducted to address their needs."

Answered by AI

Are there a variety of sites in the US currently executing this clinical study?

"This clinical trial has 12 participating health centres, such as Newark Beth Israel in Newark, Advocate Christ Medical Center in Oak Lawn, and Royal Victoria Hospital - McGill University in Montreal. Additionally, there are an additional 9 medical sites that are part of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair

2008. "Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00630266.

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