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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 belowSelect...
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
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
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
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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