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Transcatheter Mitral Valve Repair
SAPIEN M3 System for Mitral Regurgitation (SAPIEN M3 EFS Trial)
N/A
Waitlist Available
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
High risk of cardiovascular surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
SAPIEN M3 EFS Trial Summary
This trial will study whether it is safe to implant the SAPIEN M3 System in patients with severe MR, and will also provide information to help plan future clinical studies using this system.
Who is the study for?
This trial is for adults with severe mitral valve regurgitation who are at high risk for heart surgery, stable on heart failure meds, and not pregnant. They must understand the study and consent to it. Excluded are those with other valve issues, mechanical aortic valves, history of certain cardiovascular events or procedures within specified time frames, participation in another study, refusal of blood products, specific cardiac conditions that could interfere with treatment effectiveness or safety.Check my eligibility
What is being tested?
The Edwards SAPIEN M3 System is being tested to see if it's safe and works well for treating severe symptomatic mitral regurgitation (MR). The trial will help design future studies by collecting initial data on this new medical device's performance.See study design
What are the potential side effects?
While the side effects aren't listed here specifically for the SAPIEN M3 System, similar interventions may include complications like bleeding at the catheter site, infection risks from invasive procedures, potential damage to nearby heart structures during implantation.
SAPIEN M3 EFS 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...
I am at high risk for heart surgery.
SAPIEN M3 EFS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Technical Success
Secondary outcome measures
Reduction in mitral regurgitation (MR)
SAPIEN M3 EFS Trial Design
1Treatment groups
Experimental Treatment
Group I: TMVRExperimental Treatment1 Intervention
Subjects will undergo transcatheter mitral valve replacement
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
62,316 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.Your heart's shape would make it difficult to put in the device or valve correctly.I have kidney problems or am on dialysis.I have liver disease or abnormal liver test results.I am currently pregnant or breastfeeding.It is expected that you will live for less than 12 months.Your heart imaging shows a mass, blood clot, or infection.You have a high risk of blockage in the left ventricular outflow tract.Your heart's pumping ability is less than 30%.My condition cannot be treated with surgery.I've had surgery on my mitral valve that may interfere with new treatments.I have had unexplained blood clots in my veins or lungs more than once.I have not had any heart or carotid artery procedures in the last 30 days.I have a blood disorder affecting my white cells, red cells, or platelets.I have serious heart artery problems that haven't been treated.I have not had active bacterial endocarditis in the last 6 months.I cannot take blood thinning medications due to a health condition.You have heart problems that affect your ability to do physical activities.I haven't been hospitalized for heart failure or needed heart support in the last 30 days.I need a heart valve replacement.I have not had a heart attack in the last 30 days.I am at high risk for heart surgery.I have not had a stroke or mini-stroke in the last 3 months.You have had a heart transplant in the past.You have a mechanical aortic valve implant.I refuse to receive blood transfusions.My heart's right side is not pumping well.You have a high level of MR (mitral regurgitation) in your heart.I have severe, untreatable high blood pressure in my lungs.My heart condition has been stable on medication for at least 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: TMVR
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.
Mitral Valve Regurgitation Patient Testimony for trial: Trial Name: NCT03230747 — N/A
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