N/A N=27 Randomized Single-blind Treatment

Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03937570 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: VO2 Peak — 13.2; 13.8; 14.2; 13.2 mL/Kg/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: echo-optimization (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Universita di Verona
Primary completion: Dec 2019

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	—

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.

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 …).

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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.