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Transcatheter Mitral Valve Replacement
TMVR for Mitral Valve Disease (INTERLUDE Trial)
N/A
Waitlist Available
Led By Mat Williams, M.D.
Research Sponsored by Caisson Interventional LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has severe mitral regurgitation
New York Heart Association (NYHA) Class II, III, IVa or heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operative
Awards & highlights
INTERLUDE Trial Summary
This trial is testing a new minimally-invasive treatment for people with a specific heart condition. The goal is to see if it's safe and effective.
Who is the study for?
This trial is for individuals at high risk for heart surgery with severe, symptomatic mitral regurgitation and classified as NYHA Class II-IVa. It's not suitable for those with excessive calcification of the mitral valve, severe right ventricular dysfunction, recent stroke or heart attack, or certain other heart conditions.Check my eligibility
What is being tested?
The study is evaluating a Transcatheter Mitral Valve Replacement (TMVR) system to treat severe mitral regurgitation. The goal is to determine how safe and effective this minimally invasive procedure is in improving heart function.See study design
What are the potential side effects?
Potential side effects may include bleeding, infection at the catheter insertion site, irregular heartbeat patterns (arrhythmias), damage to the blood vessels where the catheter was inserted, kidney problems from contrast dye used during the procedure, and risks associated with anesthesia.
INTERLUDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe leakage in my heart's mitral valve.
Select...
My heart condition limits my physical activity.
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I am at high risk for heart surgery.
INTERLUDE Trial 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
Number of patients without Major Adverse Events (MAEs)
Secondary outcome measures
Prosthesis
Number of patients with successful delivery and implantation of the prosthetic valve (technical success)
INTERLUDE Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcatheter Mitral Valve ReplacementExperimental Treatment1 Intervention
Patients with symptomatic mitral regurgitation (garde 3 or 4), determined to be a high risk for cardiovascular surgery, will be treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcatheter Mitral Valve Replacement
2015
N/A
~100
Find a Location
Who is running the clinical trial?
Caisson Interventional LLCLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Mat Williams, M.D.Principal InvestigatorNYU Langone Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blockage in the heart affecting blood flow.I have not had a stroke in the last 90 days.I have not had a stroke or heart attack in the last 30 days.I have severe leakage in my heart's mitral valve.My heart condition limits my physical activity.I am at high risk for heart surgery.I have a serious heart valve problem.Your heart's left ventricle is larger than 7 centimeters when it's full of blood.My heart's right side is not pumping well.My heart's mitral valve has excessive calcification or thickening.
Research Study Groups:
This trial has the following groups:- Group 1: Transcatheter Mitral Valve Replacement
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 have any opportunities for prospective participants?
"According to clinicaltrials.gov, the recruitment of participants for this trial has been paused since January 27th 2020. Despite its current inactive state, 444 other trials are actively recruiting patients at present time."
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