Health Trials

About this trial

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Eligibility criteria

Qualifiers

Eighteen (18) years of age or older

Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.

Severe or greater tricuspid regurgitation

New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months

Disqualifiers

Tricuspid valve anatomy not evaluable by TTE or TEE

Tricuspid valve anatomy precludes proper device deployment and function

Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)

Would prevent proper TR reduction due to interaction of the lead with the leaflets

Trial design

Treatments tested in this trial

  • Edwards PASCAL System
  • Optimal Medical Therapy
  • Edwards PASCAL System
  • Edwards PASCAL System

Treatment groups

1,270 Participants
are divided into 4 treatment groups

Locations

79
Canada
St. Paul's HospitalV6Z 1Y6, VancouverBritish Columbia, Canada
Hamilton Health ServicesL8L 2X2, HamiltonOntario, Canada
University of Ottawa Heart InstituteK1Y 4Q7, OttawaOntario, Canada
St. Michael's HospitalM5B 1W8, TorontoOntario, Canada

Sponsors and collaborators

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov