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

This trial does not accept healthy volunteers

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 population

Real-world patients with symptomatic, severe or greater tricuspid regurgitation in the United States

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

The TriClip System
Device
The TriClip System

Treatment groups

2,200 Participants

are divided into 2 treatment groups

Group A: Treatment Group1 intervention

Group B: Control Group0 interventions

Trial outcomes

Primary outcomes

Composite of heart failure hospitalization or all-cause mortality

Compare the rate of composite endpoint at 2 years between the treatment and control groups.

Time frame

2 years

Secondary outcomes

Tricuspid valve re-intervention

Report the rate at 2 years for the treatment group

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbott Medical Devices

Lead sponsor

Source ClinicalTrials.gov

Apply now