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Optimized Biventricular Pacing Allograft Recipients (BiBET)

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University

Tracking Information
First Submitted Date  ICMJE February 2, 2011
First Posted Date  ICMJE February 7, 2011
Results First Submitted Date  ICMJE May 26, 2016
Results First Posted Date  ICMJE August 15, 2016
Last Update Posted Date October 6, 2016
Study Start Date  ICMJE January 2007
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01290822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
  • Atrial Latency [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  • 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.
  • Peak LV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  • Peak RV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  • Interventricular Synchrony [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
  • Atrial Latency [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  • Interatrial Delay (Between Right Atrium and Left Atrium) [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  • Peak LV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  • Peak RV dP/dt [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
  • Interventricular Synchrony [ Time Frame: 13 minutes of testing; performed before CPB for allograft receipt ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimized Biventricular Pacing Allograft Recipients
Official Title  ICMJE Optimized Biventricular Pacing in Allograft Recipients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Dilated Cardiomyopathy
  • Ischemic Cardiomyopathy
Intervention  ICMJE
  • Device: BiVP
    Biventricular pacing
    Other Name: Biventricular Pacing
  • Device: AAI Pacing
    Atrial pacing
    Other Name: Atrial Pacing
Study Arms  ICMJE
  • Experimental: BiVP Pacing
    BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.
    Intervention: Device: BiVP
  • Active Comparator: AAI Pacing
    Traditional atrial (AAI) pacing
    Intervention: Device: AAI Pacing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 5, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2011)
72
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01290822
Other Study ID Numbers  ICMJE AAAC1492
1R01HL080152-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Henry M. Spotnitz, Columbia University
Study Sponsor  ICMJE Henry M. Spotnitz
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Henry M Spotnitz, MD Columbia University
PRS Account Columbia University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP