Trial Outcomes & Findings for Biventricular Pacing After Cardiopulmonary Bypass (NCT NCT00498940)
NCT ID: NCT00498940
Last Updated: 2018-02-22
Results Overview
Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
24 hours
Results posted on
2018-02-22
Participant Flow
Enrollment began on April 1, 2007 and ended March 1, 2012. The trial was conducted at Columbia University and University of California, Lost Angeles.
Enrolled patients not meeting study criteria just prior to the start of study, withdrawn at surgeon's discretion, or change in surgery type were not randomized. 61 out of the 111 enrolled subjects were randomized, received study intervention and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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biventricular Pacing After Cardiopulmonary Bypass
Baseline characteristics by cohort
| Measure |
Biventricular Pacing
n=30 Participants
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
n=31 Participants
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
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
67.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ejection Fraction (%)
|
34 percentage of ventricular blood pumped
STANDARD_DEVIATION .1 • n=5 Participants
|
32 percentage of ventricular blood pumped
STANDARD_DEVIATION .2 • n=7 Participants
|
33 percentage of ventricular blood pumped
STANDARD_DEVIATION .1 • n=5 Participants
|
|
QRS duration (ms)
|
120.1 msec
STANDARD_DEVIATION 27.9 • n=5 Participants
|
118.6 msec
STANDARD_DEVIATION 23.0 • n=7 Participants
|
119.3 msec
STANDARD_DEVIATION 25.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursCardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.
Outcome measures
| Measure |
Biventricular Pacing
n=23 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).
|
2.83 L/min/m^2
Standard Error .16
|
2.52 L/min/m^2
Standard Error .13
|
SECONDARY outcome
Timeframe: 30 days after surgeryThis is to measure the total number of subjects that experienced any of the following complications: sepsis/infection, renal failure, respiratory failure/complications, bleeding requiring reoperation, cerebrovascular accident.
Outcome measures
| Measure |
Biventricular Pacing
n=30 Participants
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
n=31 Participants
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.
|
|---|---|---|
|
Number of Subjects With Postoperative Complications
|
10 participants
|
10 participants
|
Adverse Events
Biventricular Pacing
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Biventricular Pacing
n=30 participants at risk
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
n=31 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Bleeding at lead site
|
3.3%
1/30
|
0.00%
0/31
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/30
|
3.2%
1/31
|
Additional Information
Santos Cabreriza/ Associate Scientist
Columbia University Medical Center
Phone: 212-305-9515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place