Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Device: SAPIEN 3 THV; Biological: 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

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-22
• Study Start: 2016-09
• Primary Completion: 2023-02-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Not provided

Exclusion Criteria

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)

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

UCSF; 🇺🇸 San Francisco, California, United States

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

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