Clinical Trials

Clinical Trial Number: NCT03382457

Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

Study ID: NCT03382457
Phase N/A
Physician Investigator(s)
Study Locations

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System

Eligibility Criteria

Inclusion Criteria:

  • Chronic functional tricuspid regurgitation (moderate or greater)
  • Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
  • The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction

Exclusion Criteria:

  • Unsuitable anatomy
  • Primary tricuspid valve disease
  • Previous tricuspid valve repair or replacement with device in place
  • Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study