An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)

An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04483089

Acronym

bRIGHT

Enrollment

511

Registered

2020-07-23

Start date

2020-08-27

Completion date

2028-01-01

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Valve Regurgitation

Brief summary

The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).

Detailed description

The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.

Interventions

DEVICETranscatheter heart valve procedure

Transcatheter treatment of TR with Abbott TriClip™.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy. 2. Subjects eligible to receive the TriClip™ per the current approved Indications for Use. 3. Subject must provide written informed consent prior to study procedure.

Exclusion criteria

1\. Subjects participating in another clinical study that may impact the follow-up or results of this study.

Design outcomes

Primary

Measure	Time frame	Description
Acute Procedural Success (APS)	up to 30 days	The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure.

Secondary

Measure	Time frame	Description
Composite endpoint of all-cause mortality or TR re-intervention	at 1 year follow-up	The secondary endpoint is a composite endpoint of all-cause mortality or tricuspid valve re-intervention/re-operation at 1 year.

Countries

Austria, Denmark, Germany, Italy, Netherlands, Portugal, Spain, Switzerland

Contacts

STUDY_DIRECTORMeghan Griffin

Clinical Program Director

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026