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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 below
Select...
I have severe leakage in my heart's mitral valve.
Select...
My heart condition limits my physical activity.
Select...
I am at high risk for heart surgery.

INTERLUDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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

Transcatheter Mitral Valve Replacement (Transcatheter Mitral Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT03661398 — N/A
Mitral Valve Regurgitation Research Study Groups: Transcatheter Mitral Valve Replacement
Mitral Valve Regurgitation Clinical Trial 2023: Transcatheter Mitral Valve Replacement Highlights & Side Effects. Trial Name: NCT03661398 — N/A
Transcatheter Mitral Valve Replacement (Transcatheter Mitral Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03661398 — N/A

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."

Answered by AI
~10 spots leftby Mar 2025