Status:

COMPLETED

Development & Testing of a Decision Aid for LVAD Placement

Lead Sponsor:

Baylor College of Medicine

Collaborating Sponsors:

The Methodist Hospital Research Institute

The University of Texas Health Science Center, Houston

Conditions:

End-Stage Heart Failure

Bridge-to-Transplant LVAD Placement (BTT)

Eligibility:

All Genders

30-85 years

Phase:

NA

Brief Summary

The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment. This study seeks to create a decision aid that presents outcomes, ri...

Eligibility Criteria

Inclusion

  • LVAD Candidates (NYHA Class III and IV patients with an acceptable surgical risk/benefit ratio for LVAD implantation and with good psychosocial support, coping mechanisms, and financial resources, as determined by "clearance" from the transplant social worker)
  • LVAD Patients
  • LVAD Decliners
  • LVAD Caregivers

Exclusion

  • subjects who lack the capacity to give informed consent

Key Trial Info

Start Date :

February 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2017

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT02248974

Start Date

February 1 2014

End Date

January 1 2017

Last Update

May 31 2019

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Ochsner Health System

New Orleans, Louisiana, United States, 70115

2

Cleveland Clinic

Cleveland, Ohio, United States, 44195

3

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States, 73112

4

CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute

Houston, Texas, United States, 77030