Triluminate Pivotal Study

Summary

This study focuses on patients who have severe or greater tricuspid regurgitation (TR) and who have symptoms due to heart failure despite being treated with currently available therapies. TR occurs when the leaflets of the tricuspid valve do not close properly, causing blood to leak backward with each heartbeat. The purpose of the study is to compare the performance of an investigational tricuspid valve repair system (TriClip Device) plus optimal drug therapy with optimal drug therapy alone. The device consists of a delivery catheter and an implantable tricuspid valve repair clip (the TriClip) to repair the tricuspid valve. Participants will be randomly assigned to one of two study groups: the device group (those who receive the TriClip device) or the No TriClip device group (control/medical therapy group).


Inclusion Criteria

  • In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
  • Optimized medical therapy for treatment of TR (e.g. diuretics).
  • Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
Show more

Study Location(s)

Beverly

More about this Clinical Trial

Full Title

Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal

Details
Disease Type/Condition

Valvular Heart Disease

Principal Investigator

Makkar, Rajendra

Co-Investigators

Alfredo Trento, Danny Ramzy, Mamoo Nakamura, Moody Makar, Sabah Skaf, Siddharth Singh, Tarun Chakravarty, Wen Cheng

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000142

ClinicalTrials.gov ID

NCT03904147

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Valvular Heart Disease

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

N/A

IRB Number

ABT-CIP-10249

ClinicalTrials.gov ID

NCT03904147

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?