Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)

NCT ID: NCT01446796

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-10-31

Brief Summary

Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure. However, little is known about RV pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (LVAD). The univentricular support provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart failure patients, yet the incidence of RV failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing may counteract these adverse mechanical alterations, improving RV systolic function and ultimately LVAD function.

The investigators will recruit all patients referred for an implantable, continuous flow LVAD at Duke University Medical Center who have an existing implantable dual-chamber cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. Multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, RV function by Echocardiography as well as patient symptoms and functional status.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Native Conduction

Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.

Group Type: PLACEBO_COMPARATOR

Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)

Intervention Type: DEVICE

Pacing parameters set to AAI 90

Continuous RV Pacing

Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (\>80%) of paced right ventricular beats

Group Type: EXPERIMENTAL

Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)

Intervention Type: DEVICE

Pacing parameters set to DDD 90-100

Interventions

Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)

Pacing parameters set to AAI 90

Intervention Type: DEVICE

Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)

Pacing parameters set to DDD 90-100

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old, both men and women
• Existing implantable cardioverter-defibrillator (ICD)
• Referred for implantation of a continuous flow LVAD

Exclusion Criteria

• Permanent left ventricular epicardial defibrillator in place
• Congenital heart disease with single ventricle physiology
• Right ventricular assist device (RVAD) in place
• Existing pacing indication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00026676

Identifier Type: -

Identifier Source: org_study_id