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Mitral Valve Repair Device

Mitral Valve Repair Device for Mitral Regurgitation

N/A
Waitlist Available
Led By Satya Shreenivas, 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 II-IV (i.e., ambulatory)
Study patient is at least 18-years old
Must not have
Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration System (e.g., femoral arteries will not support a 20F system)
NYHA class IV (i.e., non-ambulatory) or American College of Cardiology (ACC)/American Heart Association (AHA) Stage D heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-day
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device to treat heart failure and concomitant mitral regurgitation.

Who is the study for?
This trial is for adults over 18 with heart failure and moderate to severe mitral valve regurgitation who are high-risk surgical candidates but stable on heart failure medication. They must have an ejection fraction between 20-60% and be in NYHA class II-IV, meaning they can still walk around.
What is being tested?
The study tests the AccuCinch® Ventricular Restoration System's effectiveness in patients with symptomatic heart failure and functional mitral regurgitation. It's a non-randomized, early feasibility study across multiple centers focusing on those already on medical therapy.
What are the potential side effects?
While specific side effects aren't listed here, typical risks of mitral valve repair procedures may include bleeding, infection, blood clots leading to stroke or other problems, arrhythmias (irregular heartbeats), renal impairment, or issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have some difficulty with physical activity due to my heart condition.
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I am 18 years old or older.
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My heart's pumping ability is between 20% and 60%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My body cannot support the AccuCinch® system due to physical limitations.
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I have severe heart failure and cannot walk or do daily activities.
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My kidney function is severely reduced.
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I need help with my daily activities due to my condition.
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I have a serious condition affecting my mitral valve.
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I have been diagnosed with severe tricuspid regurgitation.
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I have low blood pressure or need support to maintain my blood circulation.
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I have a serious issue with my aortic valve or have an artificial one.
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I have an ongoing heart infection.
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I have a heart condition other than dilated cardiomyopathy causing heart failure.
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I have a serious heart artery problem that hasn't been treated with surgery.
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I do not have any heart surgery or procedures planned in the next 6 months.
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I have had surgery or a procedure on my mitral valve.

Timeline

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
30-Day Safety

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AccuCinch® Ventricular Restoration SystemExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitral valve repair
2011
N/A
~320

Find a Location

Who is running the clinical trial?

Ancora Heart, Inc.Lead Sponsor
8 Previous Clinical Trials
585 Total Patients Enrolled
6 Trials studying Heart Failure
561 Patients Enrolled for Heart Failure
Satya Shreenivas, MDPrincipal InvestigatorThe Christ Hospital
Michael Zapien, MS, CCRAStudy DirectorAncora Heart, Inc. (formerly Guided Delivery Systems Inc.)
3 Previous Clinical Trials
159 Total Patients Enrolled
3 Trials studying Heart Failure
159 Patients Enrolled for Heart Failure

Media Library

AccuCinch® Ventricular Restoration System (Mitral Valve Repair Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02806570 — N/A
~4 spots leftby Nov 2025
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