RECRUITING

TriClip CED RWE Study

Description

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
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Related Conditions:

Tricuspid Regurgitation

Study Overview

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Study Details

Study overview

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.

TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)

TriClip CED RWE Study

Condition
Tricuspid Regurgitation
Intervention / Treatment

-

Contacts and Locations

Santa Clara

Abbott, Santa Clara, California, United States, 95054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Study Record Dates

2032-07