TriClip CED RWE Study

ConditionTricuspid Regurgitation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAbbott Medical Devices

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

The TriClip System

Treatment groups

2,200 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Abbott Medical Devices

Lead sponsor

Source ClinicalTrials.gov