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

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ClinicalTrials.gov Identifier: NCT04483089
Recruitment Status : Active, not recruiting
First Posted : July 23, 2020
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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).

Condition or disease Intervention/treatment
Tricuspid Valve Regurgitation 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 Design
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Study Type : Observational
Actual Enrollment : 501 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : January 2028
Groups and Cohorts
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Intervention Details:
  • Device: Transcatheter heart valve procedure
    Transcatheter treatment of TR with Abbott TriClip™.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483089


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Erin Spinner Clinical Program Director
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04483089    
Other Study ID Numbers: ABT-CIP-10317
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases