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Mitral Valve Repair Device
Transcatheter Mitral Valve Repair for Mitral Valve Regurgitation (CLASP Trial)
N/A
Waitlist Available
Led By Gideon Cohen, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eighteen (18) years of age or older
New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year, 2 year
Awards & highlights
CLASP Trial Summary
This trial is testing a new device to treat people with mitral valve disease. The device is placed in the heart through a catheter, and is intended to repair the valve without open surgery.
Who is the study for?
This trial is for adults over 18 with heart failure symptoms despite treatment, who are candidates for mitral valve repair or replacement. They must have significant mitral valve regurgitation confirmed by specific heart imaging tests and a sufficiently large mitral valve area. People can't join if they have certain right-sided heart issues, life expectancy under 12 months, participation in other trials without reaching the primary endpoint, guardianship status, unsuitable leaflet anatomy for the device implantation or a small mitral valve area.Check my eligibility
What is being tested?
The study is evaluating the Edwards PASCAL Transcatheter Mitral Valve Repair System's safety and effectiveness in improving clinical outcomes for patients with serious mitral valve regurgitation—a condition where blood leaks backward into the heart due to a faulty valve.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications related to heart procedures such as bleeding, infection at the catheter insertion site, damage to blood vessels or valves from device placement and general risks associated with anesthesia.
CLASP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My heart condition limits my physical activity despite treatment.
Select...
My heart team has approved me for mitral valve surgery.
CLASP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 1 year, 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 1 year, 2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Success
Device Success
Number of Participants With Major Adverse Events (MAE)
+1 moreSecondary outcome measures
All-cause Mortality
Change NT-pro-BNP Level
Change in BNP Level
+14 moreCLASP Trial Design
1Treatment groups
Experimental Treatment
Group I: Edwards PASCAL Transcatheter Mitral Valve Repair SystemExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitral Valve Repair
2008
N/A
~310
Find a Location
Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,450 Total Patients Enrolled
Gideon Cohen, MDPrincipal InvestigatorSunnybrook Hospital
Molly Szerlip, MDPrincipal InvestigatorThe Heart Hospital Baylor
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mass, blood clot, or infection in your heart as seen on an echocardiogram.My heart team has approved me for mitral valve surgery.I have been diagnosed with serious mitral valve leakage.I have severe right-sided heart failure confirmed by a heart ultrasound.Your mitral valve area is less than 4.0 cm². If it can't be measured directly, a different measurement is acceptable.I am 18 years old or older.My heart condition limits my physical activity despite treatment.My heart valve shape may not allow for a specific device placement.Your mitral valve area is larger than 4.0 cm² when measured by a specific method. If it can't be measured that way, another method can be used.I am under legal guardianship.
Research Study Groups:
This trial has the following groups:- Group 1: Edwards PASCAL Transcatheter Mitral Valve Repair System
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.
Does this research endeavor still have availability for participants?
"According to the data presented on clinicaltrials.gov, this particular study is not enrolling patients at present; however, it was initially posted in June 2017 and most recently updated in July 2022. On the other hand, there are currently 98 other trials that remain open for recruitment."
Answered by AI
How many locations within the state are administering this clinical research?
"For this trial, St Michael Hospital in Los Angeles, Cedars-Sinai Medical Center of Charlottesville, and the University of Virginia Health System from Charlotte are actively recruiting patients. There are also 11 other locations participating in the experiment."
Answered by AI
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