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Transcatheter Tricuspid Valve Reconstruction

Transcatheter Tricuspid Valve Reconstruction for Tricuspid Regurgitation

N/A
Waitlist Available
Led By Firas Zahr, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic functional tricuspid regurgitation (moderate or greater)
Be older than 18 years old
Must not have
Unsuitable anatomy
Primary tricuspid valve disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Summary

This trial will test the safety and performance of a new device to treat tricuspid valve disease.

Who is the study for?
This trial is for adults with chronic functional tricuspid regurgitation (moderate or greater) who still have symptoms despite medical treatment. Candidates should be deemed appropriate for the procedure by a Heart Team but cannot have unsuitable anatomy, primary valve disease, prior repairs or replacements, or conditions that may affect study participation.
What is being tested?
The Edwards Cardioband Tricuspid Valve Reconstruction System is being tested in this clinical study. It's a minimally invasive procedure designed to repair the heart's tricuspid valve without needing open-heart surgery.
What are the potential side effects?
Potential side effects might include bleeding, infection at the catheter insertion site, damage to the heart or blood vessels, irregular heartbeats, and possible need for additional procedures if initial reconstruction isn't successful.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a long-term moderate or severe leak in my heart valve.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My body's structure makes me ineligible for the procedure.
Select...
My heart condition is related to the tricuspid valve.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Performance Endpoint - Clinical Success
Primary Performance Endpoint - Intraprocedural Success
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
Secondary study objectives
Clinical Success
Device Success
Procedural Success

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the Edwards Cardioband FIT Repair System

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,966 Total Patients Enrolled
Firas Zahr, MDPrincipal InvestigatorOregon Health and Science University
William Gray, MDPrincipal InvestigatorLankenau Heart
8 Previous Clinical Trials
3,035 Total Patients Enrolled

Media Library

Edwards Cardioband Tricuspid Valve Reconstruction System (Transcatheter Tricuspid Valve Reconstruction) Clinical Trial Eligibility Overview. Trial Name: NCT03382457 — N/A
Tricuspid Regurgitation Research Study Groups: Treatment
Tricuspid Regurgitation Clinical Trial 2023: Edwards Cardioband Tricuspid Valve Reconstruction System Highlights & Side Effects. Trial Name: NCT03382457 — N/A
Edwards Cardioband Tricuspid Valve Reconstruction System (Transcatheter Tricuspid Valve Reconstruction) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03382457 — N/A
~14 spots leftby Dec 2026
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