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

NCT02661451 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2024-11-27

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

SAPIEN 3 THV

BIOLOGICAL

Optimal Heart Failure Therapy

Sponsors & Collaborators

  • Cardialysis BV

    collaborator INDUSTRY

  • Avania

    collaborator INDUSTRY

  • Cardiovascular Research Foundation, New York

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2023-02-28
Completion
2025-02-28

Countries

  • United States
  • Canada
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02661451 on ClinicalTrials.gov