Trial Outcomes & Findings for Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery (NCT NCT00397514)

NCT ID: NCT00397514

Last Updated: 2017-12-18

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline and after 20 minutes of pacing
• Results posted on: 2017-12-18

Participant Flow

34 patients were recruited between October 1, 2006 and May 31, 2008.

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.

Participant milestones

Measure	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.
Overall Study STARTED	34
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Pacing wire malfunction	1
Overall Study Not able to capture & pace LV intraoper.	4
Overall Study early extubation	2
Overall Study poor echocardiographic windows	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Congenital Heart Disease Patients n=25 Participants Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
Age, Categorical <=18 years	25 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous Age, Continuous	5.2 months n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment Canada	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 20 minutes of pacing

Outcome measures

Measure	BiV Pacing n=25 Participants Cardiac Index when patient's extubation with 20 min. of biventricular pacing	RV Pacing n=25 Participants Cardiac Index when patient's extubation with 20 min. of right ventricular pacing	Baseline n=25 Participants QRS duration at baseline
Cardiac Index	3.42 L/min/m2 Interval 1.03 to 8.4	3.23 L/min/m2 Interval 1.14 to 7.36	3.39 L/min/m2 Interval 1.28 to 9.56

Outcome measures

Outcome data not reported

Outcome measures

Outcome data not reported

Outcome measures

Outcome data not reported

Outcome measures

Outcome data not reported

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and after 20 minutes of pacing

Outcome measures

Measure	BiV Pacing n=25 Participants Cardiac Index when patient's extubation with 20 min. of biventricular pacing	RV Pacing n=25 Participants Cardiac Index when patient's extubation with 20 min. of right ventricular pacing	Baseline n=25 Participants QRS duration at baseline
QRS Duration	100 ms Interval 80.0 to 100.0	100 ms Interval 60.0 to 160.0	80 ms Interval 60.0 to 140.0

SECONDARY outcome

Timeframe: Baseline and after 20 minutes

Outcome measures

Measure	BiV Pacing Cardiac Index when patient's extubation with 20 min. of biventricular pacing	RV Pacing Cardiac Index when patient's extubation with 20 min. of right ventricular pacing	Baseline n=25 Participants QRS duration at baseline
Cardio-pulmonary Bypass Time	—	—	96 min. Interval 55.0 to 236.0

Adverse Events

Pacing Protocol and RV Pacing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shubhayan Sanatani

University of British Columbia

Phone: 6048752345

Email: ssanatani@cw.bc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place