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
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|Condition or disease||Intervention/treatment|
|Tricuspid Valve Regurgitation||Device: Transcatheter heart valve procedure|
|Study Type :||Observational|
|Actual Enrollment :||501 participants|
|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|
- Device: Transcatheter heart valve procedure
Transcatheter treatment of TR with Abbott TriClip™.
- 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.
- 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.
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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|
- 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.
1. Subjects participating in another clinical study that may impact the follow-up or results of this study.
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
|Study Director:||Erin Spinner||Clinical Program Director|
|Responsible Party:||Abbott Medical Devices|
|Other Study ID Numbers:||
|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|
|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|
Tricuspid Valve Insufficiency
Heart Valve Diseases