← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

Composite Major Adverse Event (MAE) Rate

Secondary outcome measures

Clinical Success

Device Success

Procedural Success

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards Cardioband Tricuspid Valve Reconstruction System

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

61,519 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being recruited for the research project?

"To successfully carry out this experiment, Edwards Lifesciences must secure a total of 55 eligible volunteers. The trial will be conducted from two sites: Piedmont Heart Institute in Atlanta and Oregon Health & Science University in Portland."

Answered by AI

Are there multiple locations in this state executing the trial?

"This medical trial has 10 different sites of operations, including the Piedmont Heart Institute in Atlanta, Oregon Health & Science University in Portland and the University of Virginia Health System in Charlottesville."

Answered by AI

Recent research and studies

JACC: Cardiovascular InterventionsJournal

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation

Davidson, Charles J., D. Scott Lim, Robert L. Smith, Susheel K. Kodali, Robert M. Kipperman, Mackram F. Eleid, Mark Reisman, et al.. 2021. “Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2020.10.017.

JACC: Cardiovascular ImagingJournal

Transcatheter Tricuspid Repair with the Use of 4-dimensional Intracardiac Echocardiography

Davidson, Charles J., Sandra Abramson, Robert L. Smith, Susheel K. Kodali, Robert M. Kipperman, Mackram F. Eleid, Mark Reisman, et al.. 2022. “Transcatheter Tricuspid Repair with the Use of 4-dimensional Intracardiac Echocardiography”. JACC: Cardiovascular Imaging. Elsevier BV. doi:10.1016/j.jcmg.2021.01.029.

clinicaltrials.govStudy

Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

2018. "Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03382457.

All > Tricuspid Regurgitation