Clinical trial NCT04483089: An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device (bRIGHT)
Official title: An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tricuspid Valve Regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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™.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute Procedural Success (APS)
timeFrame: up to 30 days
Secondary outcomes:
measure: Composite endpoint of all-cause mortality or TR re-intervention
timeFrame: at 1 year follow-up
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik Graz
city: Odense
country: Denmark
facility: Odense University Hospital
city: Bonn
country: Germany
facility: University Hospital Bonn
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Leipzig Heart Center
state: Saxony
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
city: Berlin
country: Germany
facility: DRK Kliniken Köpenick
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen GmbH
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus GmbH
city: Hamburg
country: Germany
facility: UKE Hamburg (Universitatsklinik Eppendorf)
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
city: Padova
country: Italy
facility: Universita degli Studi di Padova
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Porto
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Clinical and Provincial Hospital of Barcelona
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zurich
country: Switzerland
facility: HerzKlinik Hirslanden - Klinik Hirslanden
Study officials:
affiliation: Clinical Program Director
name: Meghan Griffin
role: STUDY_DIRECTOR
References: