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

NCT03937570 | Completed Results DMC FDA Device

• 1 other identifier: 1397CESC
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

left ventricular assist device; echo-optimization; functional capacity; cardiopulmonary exercise test

Outcome Measures

Primary Outcomes (1)

• VO2 Peak

  peak oxygen uptake measured by cardiopulmonary exercise test

  three months

Secondary Outcomes (5)

• Number of Participants With LVAD-related Hospitalizations

  Three months

• QoL: The EQ-5D Questionnaire

  Three months

• Nt-proBNP

  Three months

• Right Ventricular Function

  Three months

• CPET Exercise Time

  Three months

Study Arms (2)

EO GROUP

EXPERIMENTAL

Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.

Device: echo-optimization

CONTROL GROUP

NO INTERVENTION

Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.

Interventions

echo-optimization DEVICE

LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.

EO GROUP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 …).

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Department of Cardiac Surgery, University of Verona

Verona, 37126, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Marzia Lilliu, MD, PhD
• Organization: Division of Cardiac Surgery, Department of Surgery - University of Verona

marzialilliu@gmail.com

+39 3281383539

Study Officials

• MARZIA LILLIU, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator, PhD student in Cardiovascular Sciences

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: February 8, 2018
• Primary Completion: December 30, 2019
• Study Completion: August 31, 2020
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)