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Procedure

Tricuspid Valve Replacement for Tricuspid Regurgitation (TRICURE EFS Trial)

N/A
Recruiting
Led By Gorav Ailawadi, MD
Research Sponsored by TRiCares
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
Be older than 18 years old
Must not have
Anatomical contraindications for implantation with study device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 6 months, annual for five years post-intervention
Awards & highlights
No Placebo-Only Group

Summary

"This trial will evaluate the safety and effectiveness of the TRiCares Topaz Tricuspid Valve Replacement System across multiple medical centers."

Who is the study for?
This trial is for adults with severe tricuspid valve regurgitation, who are considered at high risk for surgery by a heart team. It's not suitable for those with anatomy that doesn't fit the device, involved in another study without reaching its main goal yet, needing urgent intervention or unstable.
What is being tested?
The study tests the TRiCares Topaz Tricuspid Valve Replacement System's safety and performance. It's a forward-looking study conducted across multiple centers where participants receive this new transcatheter heart valve replacement.
What are the potential side effects?
Potential side effects may include bleeding, infection at the catheter insertion site, arrhythmias (irregular heartbeat), damage to nearby structures like blood vessels or valves, kidney problems from contrast dye used during procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe tricuspid regurgitation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My body cannot safely accommodate the study device due to its structure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of MAE
Device Success
Secondary study objectives
New York Heart Association (NYHA) Function Class
Reduction in Tricuspid Regurgitation (TR) Grade
Six minute walk test

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: Transcatheter Tricuspid Valve ReplacementExperimental Treatment1 Intervention
Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Find a Location

Who is running the clinical trial?

TRiCaresLead Sponsor
2 Previous Clinical Trials
100 Total Patients Enrolled
Gorav Ailawadi, MDPrincipal InvestigatorUniversity of Michigan Hospital and Health Systems
3 Previous Clinical Trials
2,328 Total Patients Enrolled
Susheel Kodali, MDPrincipal InvestigatorColumbia University Medical Center/ NewYork Presbyterian Hospital
5 Previous Clinical Trials
3,585 Total Patients Enrolled
~7 spots leftby Oct 2025
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