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

Duke University

Status and phase: Terminated; Phase 4

Conditions: Heart Failure

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01446796

Pro00026676

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3 participants in 2 patient groups, including a placebo group

Native Conduction

Placebo Comparator group

Description:

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.

Treatment:

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

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

Continuous RV Pacing

Experimental group

Description:

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

Treatment:

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

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