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

May 14, 2026 updated by: Abbott Medical Devices

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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™.

Study Type

Observational

Enrollment (Actual)

511

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Universitätsklinik Graz
  • Denmark
      • Odense, Denmark
        • Odense University Hospital
  • Germany
      • Bad Berka, Germany
        • Zentralklinik Bad Berka GmbH
      • Bad Oeynhausen, Germany
        • Herz-und Diabetes Zentrum NRW
      • Bad Rothenfelde, Germany
        • Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
      • Berlin, Germany
        • DRK Kliniken Köpenick
      • Dortmund, Germany
        • St.-Johannes-Hospital
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen GmbH
      • Hamburg, Germany
        • Katholisches Marienkrankenhaus GmbH
      • Hamburg, Germany
        • UKE Hamburg (Universitatsklinik Eppendorf)
      • Magdeburg, Germany
        • Otto-von-Guericke-Universität Magdeburg
      • Stuttgart, Germany
        • Robert-Bosch-Krankenhaus
      • Ulm, Germany
        • Universitatsklinikum Ulm
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • University Hospital Bonn
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Leipzig Heart Center
  • Italy
      • Cotignola, Italy
        • Maria Cecilia Hospital
      • Naples, Italy
        • Azienda Ospedaliera Monaldi
  • Netherlands
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
  • Portugal
      • Porto, Portugal
        • Centro Hospitalar Vila Nova de Gaia
  • Spain
      • Vigo, Spain
        • Hospital Álvaro Cunqueiro
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Barcelona, Spain, 08025
        • Hospital de Sant Pau
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8032
        • HerzKlinik Hirslanden - Klinik Hirslanden

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™ per the current approved Indications For Use.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Procedural Success (APS)
Time Frame: 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.
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of all-cause mortality or TR re-intervention
Time Frame: 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.
at 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Meghan Griffin, Clinical Program Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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