N/A
Completed N=27
Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)
Source: ClinicalTrials.gov NCT03937570 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: VO2 Peak — 13.2; 13.8; 14.2; 13.2 mL/Kg/min
Summary
After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an improvement on functional capacity (FC). VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by cardiopulmonary exercise test (CPET), in LVAD optimization free population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VO2 Peak |
13.2; 13.8; 14.2; 13.2 | — |
| SECONDARY Number of Participants With LVAD-related Hospitalizations |
0; 0 | — |
| SECONDARY QoL: The EQ-5D Questionnaire |
0.796; 0.804; 0.85; 0.8 | — |
| SECONDARY Nt-proBNP |
1743; 1759; 1484; 1538 | — |
| SECONDARY Right Ventricular Function |
36.5; 35.8; 36.8; 35.7 | — |
| SECONDARY CPET Exercise Time |
490; 504; 526; 499 | — |
Eligibility Criteria
Inclusion Criteria
- at least 3 months after LVAD implantation;
- compliance to the required follow-up schedule;
- age 18 or above or of legal age to give informed consent specific to state and national laws.
Exclusion Criteria
- distance of less than 150 meters on the six-minute walk test (6MWT) or impossibility to perform CPET
- recent finding of any major device-related complication (sepsis, thrombosis …).
Data sourced from ClinicalTrials.gov (NCT03937570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.