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Biventricular Pacing After Cardiopulmonary Bypass (BIPACS)

This study has been terminated.
(Accrual too slow; grant renewal unlikely; AAI as effective as BiV in Phase III)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University
ClinicalTrials.gov Identifier:
NCT00498940
First received: July 9, 2007
Last updated: April 1, 2014
Last verified: April 2014
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Device: Optimization Testing
Device: Temporary Biventricular Pacing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began on April 1, 2007 and ended March 1, 2012. The trial was conducted at Columbia University and University of California, Lost Angeles.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled patients not meeting study criteria just prior to the start of study, withdrawn at surgeon's discretion, or change in surgery type were not randomized. Exclusion criteria included atrial fibrillation, 2nd or 3rd degree atrioventricular block, congenital heart disease, intracardiac shunts, or heart rate greater than 120 bpm after bypass

Reporting Groups
  Description
Biventricular Pacing

After weaning from bypass, patients will receive temporary biventricular pacing for 24 hours. Values obtained from optimization testing will determine pacemaker settings (AVD, VVD, heart rate).

Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass.

Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours.

Standard of Care

No post operative pacing is to occur. Patients will undergo optimization testing.

Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass.


Participant Flow:   Overall Study
    Biventricular Pacing     Standard of Care  
STARTED     30     31  
COMPLETED     30     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing

After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).

Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.

Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate.

Standard of Care

No continuous pacing occurred about surgery. Patients underwent optimization testing.

Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.

Total Total of all reporting groups

Baseline Measures
    Biventricular Pacing     Standard of Care     Total  
Number of Participants  
[units: participants]
  30     31     61  
Age  
[units: years]
Mean ± Standard Deviation
  67.2  ± 11.2     67.9  ± 11.7     67.5  ± 11.4  
Gender  
[units: participants]
     
Female     9     7     16  
Male     21     24     45  
Ejection Fraction (%)  
[units: percentage of ventricular blood pumped]
Mean ± Standard Deviation
  34  ± .1     32  ± .2     33  ± .1  
QRS duration (ms)  
[units: msec]
Mean ± Standard Deviation
  120.1  ± 27.9     118.6  ± 23.0     119.3  ± 25.3  



  Outcome Measures

1.  Primary:   Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).   [ Time Frame: 24 hours ]

2.  Secondary:   Secondary End Points Include Incidence of Arrhythmias, Inotropic Support, Urine Output, Weight Gain, Morbidity, Mortality, and ICU Costs.   [ Time Frame: 30 days after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Santos Cabreriza/ Associate Scientist
Organization: Columbia University Medical Center
phone: 212-305-9515
e-mail: sc45@cumc.columbia.edu


No publications provided by Columbia University

Publications automatically indexed to this study:

Responsible Party: Henry M. Spotnitz, Columbia University
ClinicalTrials.gov Identifier: NCT00498940     History of Changes
Other Study ID Numbers: AAAB5600, R01HL080152
Study First Received: July 9, 2007
Results First Received: February 3, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration