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Mitral Valve Repair Device

Mitral Valve Repair Device for Mitral Regurgitation

N/A

Waitlist Available

Led By Dean Kereiakes, 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

Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-day

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 been following heart failure treatment as recommended for over a month.

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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%.

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I am considered high-risk but eligible for heart surgery.

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

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

Primary outcome measures

30-Day Safety

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

0 / 5Eligibility criteria met

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

Dean Kereiakes, MDPrincipal InvestigatorThe Christ Hospital

4 Previous Clinical Trials

3,223 Total Patients Enrolled

Satya Shreenivas, MDPrincipal InvestigatorThe Christ Hospital

Media Library

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

Frequently Asked Questions

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

In what number of healthcare facilities is this clinical trial currently operating?

"Patients are being accepted for this trial in 17 different locations, including the Hackensack University Medical Center of New jersey and Baylor College of Medicine St. Luke's Medical Centre in Houston, along with Intermountain Medical Centre situated in Salt Lake City, Utah."

Answered by AI

Has enrollment for this experiment begun yet?

"This study, initially posted on August 1st 2016 and last updated July 28th 2021, is no longer seeking patients. However, there are currently 916 other clinical trials actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

2016. "The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02806570.