Recruiting

T-TEER

Sponsor:

Abbott Medical Devices

Code:

NCT06920745

Conditions

Tricuspid Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The TriClip System

Study Details

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.

Conditions

Tricuspid Regurgitation

Study ID

NCT06920745

Start date

Jul 8, 2025

Status verified date

Aug, 2025

Completion date

Jul, 2032

Anticipated

Primary completion date

Jul, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

2200 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

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

Control Group

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

Interventions

The TriClip System

The TriClip System

Primary outcome measure

  • Composite of heart failure hospitalization or all-cause mortality [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

TRICARE

(408) 845-3000TRICARE@abbott.com

Locations

Abbott

Recruiting

Santa Clara, California, United States, 95054

Contacts

TRICARE

(408) 845-3000TRICARE@abbott.com

More Information

Sponsor

Abbott Medical Devices

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

  • TriClip
  • Coverage with Evidence Development
  • Tricuspid Transcatheter Edge-to-Edge Repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2025-08-11.