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TRISCEND II Pivotal Trial
Overall Recruitment Status: Active, currently enrolling
Official Title
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Region Sponsors
California - Northern
Edwards Lifesciences
Acronym KP IRB No.
Study Type Phase
Clinical Trial n/a
Study Population Description
(Adult, Older Adult) Male and Female with Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Detailed Description
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
Gender Age Limit
Male & Female 18 years & older
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
Exclusion Criteria
  • Tricuspid valve anatomic contraindications
  • Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
  • Hemodynamic instability
  • Refractory heart failure requiring advanced intervention
  • Currently participating in another investigational study in which the patient has not reached a primary endpoint

Keywords and/or Specific Medical Conditions
  • 2020-05
  • Heart Valve Diseases
  • Cardiovascular Diseases
  • Tricuspid Valve Insufficiency
  • Heart Diseases
  • Cardiology
KP Clinical Facility
  • San Francisco Medical Center
Clinical Area
  • Cardiology

Principal Investigator:
Andrew N Rassi, MD
Contact Information:
- Cardiology KPNC
-San Francisco Medical Center

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