Edwards EVOQUE System for Tricuspid Valve Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tricuspid Valve Disease+5 MoreEdwards EVOQUE System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how safe and effective the Edwards EVOQUE tricuspid valve replacement system is.

Eligible Conditions
  • Tricuspid Valve Disease
  • Tricuspid Valve Regurgitation
  • Heart Failure
  • Tricuspid Regurgitation
  • Cardiovascular Disease
  • Heart Valve Disease

Treatment Effectiveness

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement
Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index
30 days
Rate of Major Adverse Events (MAE)
6 months
TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement

Trial Safety

Trial Design

3 Treatment Groups

Optimal Medical Therapy (OMT)
1 of 3
Edwards EVOQUE System & OMT
1 of 3
Single-Arm Registry
1 of 3

Active Control

Experimental Treatment

820 Total Participants · 3 Treatment Groups

Primary Treatment: Edwards EVOQUE System · No Placebo Group · N/A

Edwards EVOQUE System & OMT
Device
Experimental Group · 1 Intervention: Edwards EVOQUE System · Intervention Types: Device
Single-Arm Registry
Device
Experimental Group · 1 Intervention: Edwards EVOQUE System · Intervention Types: Device
Optimal Medical Therapy (OMT)
Drug
ActiveComparator Group · 1 Intervention: Optimal Medical Therapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
164 Previous Clinical Trials
58,180 Total Patients Enrolled
1 Trials studying Tricuspid Valve Disease
825 Patients Enrolled for Tricuspid Valve Disease
Susheel Kodali, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
2,487 Total Patients Enrolled
James Gammie, MDPrincipal InvestigatorJohns Hopkins Health System
Vinod Thourani, MDPrincipal InvestigatorPiedmont Heart Institute
7 Previous Clinical Trials
3,469 Total Patients Enrolled
Philipp Lurz, MDPrincipal InvestigatorHerzzentrum Leipzig GmbH
Rebecca Hahn, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have symptoms of TR despite medical therapy.
Appropriate for transcatheter tricuspid valve replacement per the local heart team.