Optimized Biventricular Pacing Allograft Recipients (BiBET)

This study has been terminated.
(Slow accrual and anticipated loss of funding)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University
ClinicalTrials.gov Identifier:
NCT01290822
First received: February 2, 2011
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.


Condition Intervention Phase
Dilated Cardiomyopathy
Ischemic Cardiomyopathy
Device: BiVP
Device: AAI Pacing
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Optimized Biventricular Pacing in Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Cardiac Output [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
    The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.


Secondary Outcome Measures:
  • Atrial Latency [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
  • interatrial delay (between right atrium and left atrium) [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
  • Peak LV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
  • Peak RV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]
  • Interventricular Synchrony [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BiVP Pacing
BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.
Device: BiVP
Biventricular pacing
Other Name: Biventricular Pacing
Active Comparator: AAI Pacing
Traditional atrial (AAI) pacing
Device: AAI Pacing
Atrial pacing
Other Name: Atrial Pacing

Detailed Description:

This study is designed to increase the benefit of biventricular pacing (BiVP), which is an established therapy for advanced heart failure. The investigators will test 6 left ventricular (LV) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. Pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. Pacing by previously implanted pacemakers will be suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP), left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. Care will not be altered otherwise. Results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. Benefits of this study should include: improved patient selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New York Heart Association (NYHA) heart failure class III/IV
  • Left Ventricular Ejection Fraction (LVEF) <36%
  • QRS >120 msec

Exclusion Criteria:

  • Intracardiac shunts
  • Sinus tachycardia >120 bpm
  • Second or third degree heart block
  • Previous cardiac surgery
  • Mechanical circulatory assistance
  • Atrial fibrillation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290822

Locations
United States, New York
Columbia University Medial Center
New York, New York, United States, 10032
Sponsors and Collaborators
Henry M. Spotnitz
Investigators
Principal Investigator: Henry M Spotnitz, MD Columbia University
  More Information

No publications provided

Responsible Party: Henry M. Spotnitz, George H. Humphreys, II Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT01290822     History of Changes
Other Study ID Numbers: AAAC1492, 1R01HL080152-01A2
Study First Received: February 2, 2011
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
Biventricular pacing
Dilated Cardiomyopathy
Ischemic Cardiomyopathy
Congestive heart failure
Cardiac allograft
Cardiac surgery
AVD
VVD
LV pacing site
pacing optimization

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Ischemia
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014