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

NCT01446796 | Terminated Phase 4 Results DMC

• 1 other identifier: Pro00026676
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Ventricular assist device

Outcome Measures

Primary Outcomes (1)

• Length of Hospitalization

  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.

  14 days

Secondary Outcomes (3)

• Post-operative Need for Hemodynamic / Respiratory Support

  14 days

• Right Ventricular Function

  14 days

• Functional Capacity and Symptoms

  14 days

Study Arms (2)

Native Conduction

PLACEBO COMPARATOR

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)

Continuous RV Pacing

EXPERIMENTAL

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)

Interventions

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

Pacing parameters set to AAI 90

Native Conduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, both men and women
• Existing implantable cardioverter-defibrillator (ICD)
• Referred for implantation of a continuous flow LVAD

You may not qualify if:

• Permanent left ventricular epicardial defibrillator in place
• Congenital heart disease with single ventricle physiology
• Right ventricular assist device (RVAD) in place
• Existing pacing indication

Sponsors & Collaborators

• Duke University: lead
• Medtronic: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Results Point of Contact

• Title: Michel Khouri, MD
• Organization: Duke University Medical Center

michel.khouri@duke.edu

919 684 8111

Study Officials

• Joseph Rogers, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: October 5, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 10, 2015
• Results First Posted: November 7, 2013

Record last verified: 2015-02

Locations

US (1)