Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: SAPIEN 3 THVBiological: Optimal Heart Failure Therapy
- Registration Number
- NCT02661451
- Lead Sponsor
- Cardiovascular Research Foundation, New York
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVR (with SAPIEN 3 THV) and OHFT Optimal Heart Failure Therapy Transcatheter heart valve and Optimal Heart Failure Therapy TAVR (with SAPIEN 3 THV) and OHFT SAPIEN 3 THV Transcatheter heart valve and Optimal Heart Failure Therapy OHFT Optimal Heart Failure Therapy Optimal Heart Failure Therapy
- Primary Outcome Measures
Name Time Method Disabling Stroke 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent). 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Change in KCCQ relative to baseline 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
All-Cause Death 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
- Secondary Outcome Measures
Name Time Method -All-cause death within EATI 12 month -All-cause death within EATI
MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of: 12 month 1. All-cause death
2. Disabling stroke
3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke or clinically significant worsening of heart failure (heart failure event)
Trial Locations
- Locations (51)
HealthEast Medical Research Institute
🇺🇸Saint Paul, Minnesota, United States
Advocate Christ Hospital
🇺🇸Chicago, Illinois, United States
Chandler Regional Medical Center
🇺🇸Chandler, Arizona, United States
UCSD/Sulpizio Cardiovascular Center
🇺🇸La Jolla, California, United States
University of Southern California - Los Angeles
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
St. Joseph Hospital
🇺🇸Orange, California, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Miami
🇺🇸Miami, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Evanston Hospital/NorthShore Univ. Health System
🇺🇸Evanston, Illinois, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Ascension St. Mary's Hospital
🇺🇸Saginaw, Michigan, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Morristown Memorial
🇺🇸Morristown, New Jersey, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
PinnacleHealth Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
WellSpan York Hospital
🇺🇸York, Pennsylvania, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
IHC Health Services, Inc. dba Intermountain Medical Center
🇺🇸Murray, Utah, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
University Medical Center Utrecht
🇳🇱Utrecht, TH, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Isala Clinics
🇳🇱Zwolle, Netherlands
UCSF
🇺🇸San Francisco, California, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt Heart and Vascular
🇺🇸Nashville, Tennessee, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oregon Health Science University (OHSU)
🇺🇸Portland, Oregon, United States
Oklahoma Heart Hospital
🇺🇸Milwaukee, Wisconsin, United States
Advocate Aurora- St. Lukes
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Seton Medical Center Austin
🇺🇸Austin, Texas, United States
Virginia Commonwealth University (VCU)
🇺🇸Richmond, Virginia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States