TriClip CED RWE Study

Part of paid clinical trials in Santa Clara, California.

Sponsor
Abbott Medical Devices
Study ID
NCT06920745
Status
Recruiting
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Conditions

  • Tricuspid Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The TriClip System — DEVICE
    The TriClip System

Study Details

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.

Key Dates

Start date
Jul 8, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2032
Completion
Jul 31, 2032

Study Design

Enrollment
2,200 participants (estimated)

Arms

  • Arm: Treatment Group
    Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system
  • Arm: Control Group
    Patients with symptomatic, severe or greater TR without T-TEER

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AbbottSanta ClaraCalifornia95054
TRICARE
[email protected]
(408) 845-3000

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Abbott· Santa Clara, CA

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