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Biventricular Pacing After Cardiopulmonary Bypass (BIPACS)

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ClinicalTrials.gov Identifier: NCT00498940
Recruitment Status : Terminated (Accrual too slow; grant renewal unlikely; AAI as effective as BiV in Phase III)
First Posted : July 11, 2007
Results First Posted : May 2, 2014
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Device: Optimization Testing
Device: Temporary Biventricular Pacing

  Participant Flow

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Enrolled patients not meeting study criteria just prior to the start of study, withdrawn at surgeon's discretion, or change in surgery type were not randomized. 61 out of the 111 enrolled subjects were randomized, received study intervention and had data analyzed.

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

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 
Overall Participants Analyzed 
[Units: Participants]
 30   31   61 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.2  (11.2)   67.9  (11.7)   67.5  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  30.0%      7  22.6%      16  26.2% 
Male      21  70.0%      24  77.4%      45  73.8% 
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:   Number of Subjects With Postoperative Complications   [ Time Frame: 30 days after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Henry M. Spotnitz, Columbia University
ClinicalTrials.gov Identifier: NCT00498940     History of Changes
Other Study ID Numbers: AAAB5600
R01HL080152 ( U.S. NIH Grant/Contract )
First Submitted: July 9, 2007
First Posted: July 11, 2007
Results First Submitted: February 3, 2014
Results First Posted: May 2, 2014
Last Update Posted: February 21, 2018