TRISCEND II Pivotal Trial

Summary

This study focuses on adults who have tricuspid regurgitation (TR), a condition in which the heart's tricuspid valve does not close tightly, causing blood to flow backwards in the wrong direction. The purpose of the study is to evaluate the safety and effectiveness of an investigational device called the EVOQUE system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with severe or greater tricuspid regurgitation. The EVOQUE Valve is an artificial valve made from bovine pericardial (cow heart) tissue, nitinol (metal) frame, and a fabric skirt. The valve is designed to replace the tricuspid heart valve without open-heart surgery and is implanted using a delivery catheter.


Inclusion Criteria

  • Symptomatic tricuspid regurgitation (TR) despite medical therapy
  • TR graded as severe or greater
  • Appropriate for transcatheter tricuspid valve replacement per the local heart team
Show more

Study Location(s)

Beverly

More about this Clinical Trial

Full Title

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device

Details
Disease Type/Condition

Valvular Heart Disease

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00000967

ClinicalTrials.gov ID

NCT04482062

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

III

IRB Number

2020-05

ClinicalTrials.gov ID

NCT04482062

Key Eligibility
ClinicalTrials.gov

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