Skip to main content
Clinical Trials/NCT01446796
NCT01446796
Terminated
Phase 4

Hemodynamic and Clinical Effects of Continuous Right Ventricular Pacing in the Early Post-operative Period After Left Ventricular Assist Device Implantation

Duke University1 site in 1 country3 target enrollmentSeptember 2011
ConditionsHeart Failure

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Duke University
Enrollment
3
Locations
1
Primary Endpoint
Length of Hospitalization
Status
Terminated
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
October 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Length of Hospitalization

Time Frame: 14 days

To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.

Secondary Outcomes

  • Post-operative Need for Hemodynamic / Respiratory Support(14 days)
  • Right Ventricular Function(14 days)
  • Functional Capacity and Symptoms(14 days)

Study Sites (1)

Loading locations...

Similar Trials