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Transcatheter Repair System

Edwards FORMA Tricuspid Transcatheter Repair System for Tricuspid Valve Regurgitation

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 old
Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial is testing a new treatment for tricuspid valve disease and will help researchers understand how safe and effective it is.

Eligible Conditions
  • Tricuspid Valve Regurgitation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
Secondary outcome measures
Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success
Device Success : Count and Percentage of Patients Who Experienced Device Success
Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success

Trial Design

1Treatment groups
Experimental Treatment
Group I: Edwards FORMA Tricuspid Transcatheter Repair SystemExperimental Treatment1 Intervention
Edwards FORMA Tricuspid Transcatheter Repair System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Edwards FORMA Tricuspid Transcatheter Repair System
2015
N/A
~40

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
179 Previous Clinical Trials
61,011 Total Patients Enrolled

Frequently Asked Questions

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

What is the principal aim of this investigation?

"The primary outcome of this research project, assessed over a one-month period, is to measure the Major Adverse Event Rate. Secondary objectives consist of examining Procedure Success (device success and reduction in tricuspid regurgitation), Device Deployment rate, as well as assessing how many patients achieved successful device deployment followed by retrieval from the cardiac catheterisation laboratory."

Answered by AI

Is there capacity for enrollment in this experiment?

"According to clinicaltrials.gov, recruitment for this trial has ceased. It was first posted on December 1st 2015 and last updated on the 9th of December 2021. Although this specific study is not recruiting anymore, 40 other medical trials are currently in search of participants."

Answered by AI

Are there any U.S.-based locations that have initiated this research?

"7 recruiting centres are available for this trial, including the prestigious Lankenau Medical Center in Wynnewood, Emory University Hospital in Atlanta and Cedars-Sinai Medical Center in Los Angeles. Additionally, there are 4 other sites located across America."

Answered by AI
~4 spots leftby Mar 2025