TriClip CED RWE Study

NCT ID: NCT06920745

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-08

Study Completion Date

2032-07-31

Brief Summary

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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.

Detailed Description

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The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.

Conditions

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Tricuspid Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Group

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

The TriClip System

Intervention Type DEVICE

The TriClip System

Control Group

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

No interventions assigned to this group

Interventions

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The TriClip System

The TriClip System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Abbott

Santa Clara, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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TRICARE

Role: CONTACT

(408) 845-3000

Facility Contacts

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TRICARE

Role: primary

(408) 845-3000

Other Identifiers

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CL1028170

Identifier Type: -

Identifier Source: org_study_id

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