TRISCEND II Pivotal Trial (Study ID: Triscend II)

Phase:

N/A

Physician Investigator(s):

Study Locations:

Contact Information

Lankenau Institute for Medical Research trial

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system.

Eligibility Criteria

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

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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


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