NCT06920745

Brief Summary

This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
75mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jul 2025Jul 2032

First Submitted

Initial submission to the registry

April 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 8, 2025

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2032

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

7 years

First QC Date

April 3, 2025

Last Update Submit

August 6, 2025

Conditions

Tricuspid Regurgitation

Keywords

TriClipCoverage with Evidence DevelopmentTricuspid Transcatheter Edge-to-Edge Repair

Outcome Measures

Primary Outcomes (1)

  • Composite of heart failure hospitalization or all-cause mortality

    Compare the rate of composite endpoint at 2 years between the treatment and control groups.

    2 years

Secondary Outcomes (1)

  • Tricuspid valve re-intervention

    2 years

Study Arms (2)

Treatment Group

Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system

Device: The TriClip System

Control Group

Patients with symptomatic, severe or greater TR without T-TEER

Interventions

The TriClip SystemDEVICE

The TriClip System

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Real-world patients with symptomatic, severe or greater tricuspid regurgitation in the United States

You may qualify if:

  • Patients ≥ 18 years of age at time of implant
  • Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)

You may not qualify if:

  • Patients with less than severe Tricuspid Regurgitation
  • Patients with a prior history of surgical or transcatheter tricuspid valve replacement
  • Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott

Santa Clara, California, 95054, United States

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

TRICARE

CONTACT

(408) 845-3000TRICARE@abbott.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 10, 2025

Study Start

July 8, 2025

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

US(1)