Tricuspid valve repair for Tricuspid valve incompetence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tricuspid valve incompetence+1 More
Tricuspid valve repair - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether the TriClip device is safe and effective in improving outcomes for people with severe tricuspid regurgitation who are at risk for mortality or morbidity with tricuspid valve surgery.

Eligible Conditions
  • Tricuspid valve incompetence

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 Months

12 Months
Change in 6 Minute Walk Test (6MWT)
Cardiomyopathies
Heart failure
30 Days
Change in TR from severe to moderate or less
Freedom from major adverse events (MAE) occurring after procedure attempt

Trial Safety

Trial Design

4 Treatment Groups

Randomized Cohort
1 of 4
Continued Access Study
1 of 4
Roll-In
1 of 4
Single Arm
1 of 4

Active Control

Experimental Treatment

700 Total Participants · 4 Treatment Groups

Primary Treatment: Tricuspid valve repair · No Placebo Group · N/A

Continued Access Study
Device
Experimental Group · 1 Intervention: Tricuspid valve repair · Intervention Types: Device
Roll-In
Device
Experimental Group · 1 Intervention: Tricuspid valve repair · Intervention Types: Device
Single Arm
Device
Experimental Group · 1 Intervention: Tricuspid valve repair · Intervention Types: Device
Randomized Cohort
Device
ActiveComparator Group · 1 Intervention: Tricuspid valve repair · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tricuspid valve repair
2011
N/A
~150

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
599 Previous Clinical Trials
362,680 Total Patients Enrolled
2 Trials studying Tricuspid valve incompetence
669 Patients Enrolled for Tricuspid valve incompetence
Kartik Sundareswaran, PhDStudy DirectorAbbott Structural Heart
5 Previous Clinical Trials
2,833 Total Patients Enrolled
David Adams, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
1,350 Total Patients Enrolled
Paul Sorajja, MDPrincipal InvestigatorAllina Health System
3 Previous Clinical Trials
672 Total Patients Enrolled
Erin Spinner, PhDStudy DirectorAbbott Structural Heart
1 Previous Clinical Trials
500 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
Optimal medical therapy for treatment of TR.
You are medically eligible to participate in the study.\n
You have NYHA Functional Class II, III or ambulatory class IV heart failure.
You must provide written informed consent prior to any trial related procedure.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.