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

This study has been terminated.
(Recruitment futility)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01446796
First received: September 14, 2011
Last updated: August 14, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Hemodynamic and Clinical Effects of Continuous Right Ventricular Pacing in the Early Post-operative Period After Left Ventricular Assist Device Implantation

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Length of Hospitalization [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Post-operative Need for Hemodynamic / Respiratory Support [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.

  • Right Ventricular Function [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.

  • Functional Capacity and Symptoms [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.


Enrollment: 3
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Device: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
Pacing parameters set to AAI 90
Experimental: 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
Device: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
Pacing parameters set to DDD 90-100

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446796

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Medtronic
Investigators
Principal Investigator: Joseph Rogers, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01446796     History of Changes
Other Study ID Numbers: Pro00026676
Study First Received: September 14, 2011
Results First Received: June 21, 2013
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Ventricular assist device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014