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

NCT04153786 | Terminated

• 1 other identifier: 1403080
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• LVAD flow

  Flow is the liters per minute (L/min) of blood moved by the device.

  2-5 minutes

• LVAD power

  Power is the voltage required by the device over each cardiac cycle.

  2-5 minutes

• LVAD speed

  LVAD speed, or revolutions per minute (RPMs) of the device, is set by providers to a fixed value.

  2-5 minutes

• LVAD pulsatility index (PI)

  LVAD PI reflects the contribution of the native heart's cardiac output (or "pulse") on pump flow

  2-5 minutes

Study Arms (1)

Cohort

EXPERIMENTAL

Pacemakers will be programmed to BiV pacing, left ventricular (LV) pacing, right ventricular (RV) pacing and no pacing for five minutes each. LVAD flow will be recorded every thirty seconds for five minutes with each setting. Once the interventions have been completed, all pacemakers will be returned to their original setting.

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

Interventions

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

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.

Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who have undergone implantation of both a biventricular pacemaker and LVAD who are at least three months post-LVAD implantation and who receive routine follow-up care at the UC Davis / UC San Diego Adult Arrhythmia/ Device/ LVAD clinic.
• Potential enrollees have been directly identified by their existing medical providers in clinic, who are investigators in this study.

You may not qualify if:

• Any patients who do not present to their routine follow-up appointment at the time of this study.
• Any patients who have undergone LVAD placement less than three months prior to enrollment.

Sponsors & Collaborators

• University of California, Davis: lead
• University of California, San Diego: collaborator

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Study Officials

• Uma Srivatsa, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

• Martin Cadeiras, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: November 2, 2019
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)