ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 4738 for:    British | Canada

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
34 patients were recruited between October 1, 2006 and May 31, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Congenital Heart Disease Pts. Undergoing Biventricular Repair Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.

Participant Flow:   Overall Study
    Congenital Heart Disease Pts. Undergoing Biventricular Repair
STARTED   34 
COMPLETED   25 
NOT COMPLETED   9 
Withdrawal by Subject                1 
Pacing wire malfunction                1 
Not able to capture & pace LV intraoper.                4 
early extubation                2 
poor echocardiographic windows                1 



  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.
The number of participants analyzed was 25 due to the withdrawal of 9 participants after enrolment as specified.

Reporting Groups
  Description
Congenital Heart Disease Patients Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.

Baseline Measures
   Congenital Heart Disease Patients 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      25 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Months]
Median (Full Range)
 
Age, Continuous   5.2 
 (0.1 to 37.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  56.0% 
Male      11  44.0% 
Region of Enrollment 
[Units: Participants]
 
Canada   25 


  Outcome Measures

1.  Primary:   Cardiac Index   [ Time Frame: Baseline and after 20 minutes of pacing ]

2.  Secondary:   QRS Duration   [ Time Frame: Baseline and after 20 minutes of pacing ]

3.  Secondary:   Cardio-pulmonary Bypass Time   [ Time Frame: Baseline and after 20 minutes ]

4.  Secondary:   Systolic Blood Pressure   [ Time Frame: ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Incidence of Low Output Syndrome   [ Time Frame: ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)   [ Time Frame: ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Inotropic Support   [ Time Frame: ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Ventilatory Support   [ Time Frame: ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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.


  More Information

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
e-mail: ssanatani@cw.bc.ca



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