Clinical trial NCT01446796: Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)
Official title: Hemodynamic and Clinical Effects of Continuous Right Ventricular Pacing in the Early Post-operative Period After Left Ventricular Assist Device Implantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Ventricular assist device
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-10-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Length of Hospitalization
timeFrame: 14 days
Secondary outcomes:
measure: Post-operative Need for Hemodynamic / Respiratory Support
timeFrame: 14 days
measure: Right Ventricular Function
timeFrame: 14 days
measure: Functional Capacity and Symptoms
timeFrame: 14 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References: