RECRUITING
I'm interested ...!!
TRISCEND II Pivotal Trial
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Conditions:
🦠 Tricuspid Valve Regurgitation 🦠 Tricuspid Valve Insufficiency 🦠 Tricuspid Valve Disease 🦠 Heart Valve Diseases 🦠 Cardiovascular Diseases 🦠 Heart Failure
🗓️ Study Start (Actual) 9 April 2021
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 31 December 2029
👥 Enrollment (Estimated) 1070
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Phoenix, Arizona, United States
📍 Tucson, Arizona, United States
📍 La Jolla, California, United States
📍 Los Angeles, California, United States
📍 Sacramento, California, United States
📍 San Francisco, California, United States
📍 San Francisco, California, United States
📍 Stanford, California, United States
📍 Loveland, Colorado, United States
📍 Atlantis, Florida, United States
📍 Gainesville, Florida, United States
📍 Naples, Florida, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Chicago, Illinois, United States
📍 Indianapolis, Indiana, United States
📍 Kansas City, Kansas, United States
📍 Wichita, Kansas, United States
📍 Baltimore, Maryland, United States
📍 Baltimore, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Detroit, Michigan, United States
📍 Rochester, Minnesota, United States
📍 Kansas City, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Morristown, New Jersey, United States
📍 New Brunswick, New Jersey, United States
📍 Bronx, New York, United States
📍 Buffalo, New York, United States
📍 Manhasset, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Roslyn, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Charlotte, North Carolina, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Tulsa, Oklahoma, United States
📍 Portland, Oregon, United States
📍 Philadelphia, Pennsylvania, United States
📍 Wynnewood, Pennsylvania, United States
📍 Nashville, Tennessee, United States
📍 Nashville, Tennessee, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States
📍 Plano, Texas, United States
📍 Murray, Utah, United States
📍 Charlottesville, Virginia, United States
📍 Norfolk, Virginia, United States
📍 Seattle, Washington, United States
📍 Seattle, Washington, United States
📍 Seattle, Washington, United States
📍 Bad Oeynhausen, Germany
📍 Bonn, Germany
📍 Dresden, Germany
📍 Köln, Germany
📍 Leipzig, Germany
📍 Mainz, Germany
📍 München, Germany
More locations available...

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 July 2020
  • First Submitted that Met QC Criteria 20 July 2020
  • First Posted 22 July 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 January 2024
  • Last Update Posted 16 January 2024
  • Last Verified January 2024
I'm interested ...!!