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Trial record 23 of 4802 for:    British | Canada

Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery

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ClinicalTrials.gov Identifier: NCT00397514
Recruitment Status : Completed
First Posted : November 9, 2006
Results First Posted : August 30, 2013
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Shubhayan Sanatani, University of British Columbia

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Congenital Heart Defects
Intervention Procedure: Congenital Heart Surgery Patients
Enrollment 34

Recruitment Details 34 patients were recruited between October 1, 2006 and May 31, 2008.
Pre-assignment Details One patient was excluded due to pacing wire malfunction. Four consented but we were not able to adequately capture and pace their left ventricle intraoperatively. Two consented, but underwent early extubation, and we were not able to perform the study in time. One family withdrew from the study. One patient had poor echocardiographic windows.
Arm/Group Title Congenital Heart Disease Pts. Undergoing Biventricular Repair
Hide Arm/Group Description Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
Period Title: Overall Study
Started 34
Completed 25
Not Completed 9
Reason Not Completed
Withdrawal by Subject             1
Pacing wire malfunction             1
Not able to capture & pace LV intraoper.             4
early extubation             2
poor echocardiographic windows             1
Arm/Group Title Congenital Heart Disease Patients
Hide Arm/Group Description Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
The number of participants analyzed was 25 due to the withdrawal of 9 participants after enrolment as specified.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
25
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Months
Age, Continuous Number Analyzed 25 participants
5.2
(0.1 to 37.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 25 participants
25
1.Primary Outcome
Title Cardiac Index
Hide Description [Not Specified]
Time Frame Baseline and after 20 minutes of pacing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline BiV Pacing RV Pacing
Hide Arm/Group Description:
Cardiac Index at baseline.
Cardiac Index when patient's extubation with 20 min. of biventricular pacing
Cardiac Index when patient's extubation with 20 min. of right ventricular pacing
Overall Number of Participants Analyzed 25 25 25
Median (Full Range)
Unit of Measure: L/min/m2
3.39
(1.28 to 9.56)
3.42
(1.03 to 8.40)
3.23
(1.14 to 7.36)
2.Secondary Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame [Not Specified]
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Incidence of Low Output Syndrome
Hide Description [Not Specified]
Time Frame [Not Specified]
Outcome Measure Data Not Reported
4.Secondary Outcome
Title TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)
Hide Description [Not Specified]
Time Frame [Not Specified]
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Inotropic Support
Hide Description [Not Specified]
Time Frame [Not Specified]
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Ventilatory Support
Hide Description [Not Specified]
Time Frame [Not Specified]
Outcome Measure Data Not Reported
7.Secondary Outcome
Title QRS Duration
Hide Description [Not Specified]
Time Frame Baseline and after 20 minutes of pacing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline BiV Pacing RV Pacing
Hide Arm/Group Description:
QRS duration at baseline
QRS duration when patient's extubation with 20 min. of biventricular pacing
QRS duration when patient's extubation with 20 min. of right ventricular pacing
Overall Number of Participants Analyzed 25 25 25
Median (Full Range)
Unit of Measure: ms
80
(60 to 140)
100
(80 to 100)
100
(60 to 160)
8.Secondary Outcome
Title Cardio-pulmonary Bypass Time
Hide Description [Not Specified]
Time Frame Baseline and after 20 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Congenital Heart Disease Pts. Undergoing Biventricular Repair
Hide Arm/Group Description:
Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
Overall Number of Participants Analyzed 25
Median (Full Range)
Unit of Measure: min.
96
(55 to 236)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pacing Protocol and RV Pacing
Hide Arm/Group Description Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
All-Cause Mortality
Pacing Protocol and RV Pacing
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pacing Protocol and RV Pacing
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Pacing Protocol and RV Pacing
Affected / at Risk (%)
Total   0/11 (0.00%) 
The study was limited by a small sample.Our study patients underwent BiV pacing just prior to extubation, by which time myocardial dysfunction may have recovered, so they represented a potentially healthier subset in comparison to adults.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Shubhayan Sanatani
Organization: University of British Columbia
Phone: 6048752345 ext 7955
Responsible Party: Shubhayan Sanatani, University of British Columbia
ClinicalTrials.gov Identifier: NCT00397514     History of Changes
Other Study ID Numbers: H03-70642
H03-70642 ( Other Identifier: UBC )
First Submitted: November 7, 2006
First Posted: November 9, 2006
Results First Submitted: March 13, 2013
Results First Posted: August 30, 2013
Last Update Posted: December 18, 2017