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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446796
Recruitment Status : Terminated (Recruitment futility)
First Posted : October 5, 2011
Results First Posted : November 7, 2013
Last Update Posted : March 10, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2011
Primary Completion Date : May 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Post-operative Need for Hemodynamic / Respiratory Support [ Time Frame: 14 days ]
    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.

  2. Right Ventricular Function [ Time Frame: 14 days ]
    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.

  3. Functional Capacity and Symptoms [ Time Frame: 14 days ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01446796     History of Changes
Other Study ID Numbers: Pro00026676
First Posted: October 5, 2011    Key Record Dates
Results First Posted: November 7, 2013
Last Update Posted: March 10, 2015
Last Verified: February 2015

Keywords provided by Duke University:
Ventricular assist device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases