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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Universitätsklinikum 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 Alvaro 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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