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Tricuspid Valve Repair System

Device: TriCinch Coil System treatment for Valvular Heart Disease

N/A
Waitlist Available
Research Sponsored by 4Tech Cardio Ltd.
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, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Awards & highlights
No Placebo-Only Group

Summary

The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.

Eligible Conditions
  • Valvular Heart Disease
  • Tricuspid Regurgitation
  • Heart Valve Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

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: Device: TriCinch Coil System treatmentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

4Tech Cardio Ltd.Lead Sponsor
2 Previous Clinical Trials
42 Total Patients Enrolled
~1 spots leftby Nov 2025
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