Mechanical Support Measures of Adjustment and QOL
Trial ID or NCT#
NCT03044535
Status
RECRUITING
Purpose
The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).
Official Title
Mechanical Circulatory Support: Measures of Adjustment and Quality of Life
Eligibility Criteria
Ages Eligible for Study: Older than 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Patient with a continuous flow MCS device left (L)VAD who is more than 3 months post-implant at the following intervals: 3, 6, 12, 18, 24, 30, 36, 42, 48 months and every 6 months thereafter. Note: patients can have had prior MCS devices. 2. The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery 3. Age >= 19 years and able to speak and understand English 4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance 5. Willing to participate and able to give written informed consent Group 2
Exclusion Criteria:
- 1. Scheduled for implant of a bi-VAD, right (R)VAD, or total artificial heart Group 2 Inclusion Criteria: 1. Patient with a continuous flow MCS device left (L)VAD who is more than 3 months post-implant at the following intervals: 3, 6, 12, 18, 24, 30, 36, 42, 48 months and every 6 months thereafter. Note: patients can have had prior MCS devices. 2. The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery 3. Age >= 19 years and able to speak and understand English 4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance 5. Willing to participate and able to give written informed consent Group 2 Exclusion Criteria: 1. Has a bi-VAD, right (R)VAD, or total artificial heart
Contact us to find out if this trial is right for you.
Contact
Dipanjan Banerjee, MD, MS
650-533-2433
View on ClinicalTrials.gov
