Trial Search Results

TRISCEND II Pivotal Trial

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Stanford Investigator(s):

Intervention(s):

  • Device: Edwards EVOQUE System
  • Drug: Optimal Medical Therapy

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting