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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new device that fixes heart valves without surgery. It targets patients with tricuspid valve problems who don't respond well to other treatments. The device is inserted through a tube to repair the valve from inside the heart. The trial evaluates a minimally invasive system for reducing issues with the tricuspid valve.

Eligible Conditions
  • Tricuspid Valve Regurgitation

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
63,074 Total Patients Enrolled
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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