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

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: Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: Transcatheter heart valve procedure

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

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-Universitat 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
  • Napoli, Italy
    • Azienda Ospedaliera Monaldi
  • Padova, Italy
    • Universita degli Studi di Padova
• Netherlands
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
• Portugal
  • Porto, Portugal
    • Centro Hospitalar Vila Nova De Gaia
• Spain
  • Barcelona, Spain, 08025
    • Hospital de Sant Pau
  • Barcelona, Spain, 08036
    • Clinical and Provincial Hospital of Barcelona
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Zurich, Switzerland, 8032
    • HerzKlinik Hirslanden - Klinik Hirslanden

Participation Criteria

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

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)	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	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

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Erin Spinner, Clinical Program Director

Study record dates

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): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• 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