Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
AI Description
The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
- Who can join
- adult, older adult
- Participants
- 178
- Expected completion
- 2025-02
- Funded by
- other
Conditions studied
Aortic Valve Stenosis
What is being tested
- BIOLOGICAL: Optimal Heart Failure Therapy
- DEVICE: SAPIEN 3 THV
What it measures
- All-Cause Death, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
- Change in KCCQ relative to baseline, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
- Disabling Stroke, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
- Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent)., Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
Working with
Avania, Cardialysis BV
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Advocate Lutheran General Hospital
Park Ridge, IL
Ascension Alexian Brothers Medical Center
Elk Grove Village, IL
Ascension Seton Medical Center Austin
Austin, TX
Aurora St. Luke's Medical Center
Milwaukee, WI
Barnes-Jewish Hospital
Saint Louis, MO
Carle Foundation Hospital
Urbana, IL
Chandler Regional Medical Center
Chandler, AZ
Cleveland Clinic Weston Hospital
Weston, FL
Corewell Health William Beaumont University Hospital
Royal Oak, MI
Endeavor Health Evanston Hospital
Evanston, IL
Froedtert Hospital
Milwaukee, WI
Hospital of the University of Pennsylvania
Philadelphia, PA
Intermountain Medical Center
Murray, UT
Keck Hospital of USC
Los Angeles, CA
MaineHealth Maine Medical Center (Portland)
Portland, ME
Massachusetts General Hospital
Boston, MA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
MedStar Washington Hospital Center
Washington, DC
Morristown Medical Center
Morristown, NJ
Nebraska Medicine
Omaha, NE
Northwestern Memorial Hospital
Chicago, IL
NYU Langone Health
New York, NY
OHSU Hospital
Portland, OR
Penn State Health Holy Spirit Medical Center
Camp Hill, PA
Providence St. Joseph Hospital Orange
Orange, CA
Rhode Island Hospital
Providence, RI
Ronald Reagan UCLA Medical Center
Los Angeles, CA
St. Francis Hospital & Heart Center
Roslyn, NY
Swedish Cherry Hill Campus
Seattle, WA
The University of Vermont Medical Center
Burlington, VT
Tufts Medical Center
Boston, MA
UCHealth Medical Center of the Rockies
Loveland, CO
UCSF Health
San Francisco, CA
UPMC Presbyterian Shadyside
Pittsburgh, PA
Vanderbilt University Medical Center
Nashville, TN
VCU Medical Center
Richmond, VA
WellSpan York Hospital
York, PA
Yale New Haven Hospital
New Haven, CT
Registry entry updated 2024-11-27
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.