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Effect of Cardiac Resynchronization Therapy (CRT) on Left Ventricular Assist Device (LVAD) Function

NCT04153786 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-11-07

No results posted yet for this study

Summary

Certain patients with congestive heart failure are treated both by implantation of an LVAD, as well as implantation with a biventricular pacemaker. Both of these devices, individually, have been shown to improve the health of patients with heart failure. However, only a small number of patients have both an LVAD and a biventricular pacemaker at the same time.

Pacemakers have many different settings. However, there is little data to inform physicians which of these different settings is best for the flow of an LVAD. This study is evaluating patients who have both a biventricular pacemaker and an LVAD. Investigators will operate the pacemaker at multiple different settings and monitor the LVAD's function to determine which, if any, setting is best for the LVAD's flow.

Conditions

  • LVAD (Left Ventricular Assist Device) Driveline Infection

Interventions

OTHER

Temporary changes in an already-implanted medical device (biventricular pacemaker)

During the patient's routine clinic visit, investigators will adjust the patient's pacemaker to four different settings and monitor for any changes in the function of the LVAD. The pacemaker will be set to each new setting for 2-5 minutes. After this, the pacemaker will be returned to its original / pre-existing setting, and the patient will leave the clinic with no overall changes to the settings of either the pacemaker or LVAD. However, if investigators find that one of the four pacemaker settings results in a clear improvement in the LVAD function, the patient will be given the option of resetting their pacemaker to that new setting before leaving the clinic. In either case, the LVAD settings will not be altered at all. The adjustments will be made by the regular device staff who routinely see the patients and maintain their devices during their regular follow-up clinic visits.

Sponsors & Collaborators

Principal Investigators

  • Uma Srivatsa, MD · UC Davis

  • Martin Cadeiras, MD · UC Davis

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-02
Primary Completion
2023-11-07
Completion
2023-11-07

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153786 on ClinicalTrials.gov