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NCT Number: NCT04483089

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik Graz, Graz, Austria

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About this study

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™.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
  • Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
  • Subject must provide written informed consent prior to study procedure.

Exclusion criteria

  • Subjects participating in another clinical study that may impact the follow-up or results of this study.

Treatment and study plan

Transcatheter heart valve procedure

Device

Transcatheter treatment of TR with Abbott TriClip™.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: bRIGHT

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Jul 23, 2020
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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