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Mitral Valve Repair System
CardioMech MVRS for Mitral Valve Regurgitation
N/A
Recruiting
Led By Mayra Guerrero, MD
Research Sponsored by CardioMech AS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intermediate or high surgical risk for mitral valve repair
Eighteen (18) years of age or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial was to test a new mitral valve repair system for patients with degenerative mitral valve regurgitation. The system was found to be safe and effective.
Who is the study for?
This trial is for adults with moderate to severe mitral valve regurgitation due to prolapse or flail, who are at intermediate or high risk for surgical repair. It's not suitable for those with a history of heart infections, previous mitral valve surgeries, rheumatic heart disease, severely calcified leaflets that prevent device placement, or complex MR mechanisms.Check my eligibility
What is being tested?
The CardioMech Mitral Valve Repair System (MVRS) is being tested in this trial. The MVRS aims to safely and effectively treat degenerative mitral valve regurgitation without the need for traditional surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include complications related to device implantation such as bleeding, infection at the site of insertion, potential damage to surrounding structures during deployment and possible need for future surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at a moderate to high risk for complications from mitral valve surgery.
Select...
I am 18 years old or older.
Select...
My heart valve leaks severely due to a prolapse or flail.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in MR grade
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Trial Design
1Treatment groups
Experimental Treatment
Group I: CardioMech Mitral Valve Repair System (MVRS)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
CardioMech ASLead Sponsor
Mayra Guerrero, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
1,288 Total Patients Enrolled
Mathew Williams, MDPrincipal InvestigatorNYU Langone
4 Previous Clinical Trials
422 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your mitral valve has too much calcium buildup, making it difficult for the device to be positioned and placed properly.I have had surgery on my heart's mitral valve or a device installed in my heart.I am at a moderate to high risk for complications from mitral valve surgery.I have had rheumatic heart disease.I am 18 years old or older.I have had endocarditis before.My heart valve leaks severely due to a prolapse or flail.Your heart valve has specific complicated issues that can be seen on imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: CardioMech Mitral Valve Repair System (MVRS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 which locales has this experiment been conducted?
"Patients interested in participating can register at Intermountain Medical Center (Murray, Utah), NYU Langone (New york, New York) and Atrium Health Sanger Heart and Vascular Institute (Charlotte North carolina). Additionally, there are 6 other sites approved for recruitment."
Answered by AI
Are there still vacancies for this experiment?
"Contrary to what is reported on clinicaltrials.gov, this particular medical study does not require any more patients at the moment. This trial was initially posted on July 27th 2021 and its information was last updated on March 28th 2022; however, there are nearly one hundred other trials that are currently searching for participants."
Answered by AI
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