Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 178
- Locations
- 51
- Primary Endpoint
- Disabling Stroke
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TAVR (with SAPIEN 3 THV) and OHFT
Transcatheter heart valve and Optimal Heart Failure Therapy
Intervention: SAPIEN 3 THV (Device)
TAVR (with SAPIEN 3 THV) and OHFT
Transcatheter heart valve and Optimal Heart Failure Therapy
Intervention: Optimal Heart Failure Therapy (Biological)
OHFT
Optimal Heart Failure Therapy
Intervention: Optimal Heart Failure Therapy (Biological)
Outcomes
Primary Outcomes
Disabling Stroke
Time Frame: 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).
Time Frame: 12 months
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Change in KCCQ relative to baseline
Time Frame: 12 months
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
All-Cause Death
Time Frame: 12 months
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Secondary Outcomes
- -All-cause death within EATI(12 month)
- 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)