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

Tricuspid Valve Regurgitation Clinical Trial

— bRIGHT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04483089
• Other study ID #: ABT-CIP-10317
• Status: Active, not recruiting
• Start date: August 27, 2020
• Est. completion date: January 2028

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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™.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 511
• Est. completion date: January 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

Device:
• Transcatheter heart valve procedure
Transcatheter treatment of TR with Abbott TriClip™.

Locations

Country	Name	City	State
Austria	Universitätsklinik Graz	Graz
Denmark	Odense University Hospital	Odense
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen
Germany	Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG	Bad Rothenfelde
Germany	DRK Kliniken Köpenick	Berlin
Germany	University Hospital Bonn	Bonn	North Rhine-Westphalia
Germany	St.-Johannes-Hospital	Dortmund
Germany	Elisabeth-Krankenhaus Essen GmbH	Essen
Germany	Katholisches Marienkrankenhaus GmbH	Hamburg
Germany	UKE Hamburg (Universitatsklinik Eppendorf)	Hamburg
Germany	Leipzig Heart Center	Leipzig	Saxony
Germany	Otto-von-Guericke-Universität Magdeburg	Magdeburg
Germany	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz	Mainz	Rhineland-Palatinate
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Universitätsklinikum Ulm	Ulm
Italy	Maria Cecilia Hospital	Cotignola
Italy	Azienda Ospedaliera Monaldi	Napoli
Italy	Universita degli Studi di Padova	Padova
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Portugal	Centro Hospitalar Vila Nova de Gaia	Porto
Spain	Clinical and Provincial Hospital of Barcelona	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital Álvaro Cunqueiro	Vigo
Switzerland	Inselspital Bern	Bern
Switzerland	HerzKlinik Hirslanden - Klinik Hirslanden	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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