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Optimized Biventricular Pacing Allograft Recipients (BiBET)

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. Identifier: NCT01290822
Recruitment Status : Terminated (Slow accrual and anticipated loss of funding)
First Posted : February 7, 2011
Results First Posted : August 15, 2016
Last Update Posted : October 6, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University

Brief Summary:
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 or disease Intervention/treatment Phase
Dilated Cardiomyopathy Ischemic Cardiomyopathy Device: BiVP Device: AAI Pacing Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimized Biventricular Pacing in Allograft Recipients
Study Start Date : January 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cardiac Output [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
    The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.

Secondary Outcome Measures :
  1. Atrial Latency [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  2. Interatrial Delay (Between Right Atrium and Left Atrium) [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
    Results could not be analyzed due to poor enrollment and lack of data.

  3. Peak LV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  4. Peak RV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  5. Interventricular Synchrony [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01290822

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United States, New York
Columbia University Medial Center
New York, New York, United States, 10032
Sponsors and Collaborators
Henry M. Spotnitz
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Henry M Spotnitz, MD Columbia University

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Responsible Party: Henry M. Spotnitz, George H. Humphreys, II Professor of Surgery, Columbia University Identifier: NCT01290822    
Other Study ID Numbers: AAAC1492
1R01HL080152-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2011    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Henry M. Spotnitz, Columbia University:
Biventricular pacing
Dilated Cardiomyopathy
Ischemic Cardiomyopathy
Congestive heart failure
Cardiac allograft
Cardiac surgery
LV pacing site
pacing optimization
Additional relevant MeSH terms:
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Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases