An interventional study of Provocative electrophysiology study in Arrhythmia in Children and Congenital Heart Disease, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Diagnostic
In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. They can be due to abnormal electrical pathway or an irritable area of the heart that stimulates abnormal impulses. Regardless of the cause, arrhythmias after cardiac surgery can be a problem, extending the hospital stay, requiring additional medications and even leading to cardiac arrest.
Current practice is to monitor for arrhythmias after cardiac surgery, and to treat them if they occur. With this research, we want to investigate whether we can identify patients who will develop arrhythmia, and treat them before they occur.
This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management
3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 46 is below the median of 100 across 1,779 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be observed for arrhythmias and treated if they occur.
Patients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced.
Diagnostic Test: Provocative electrophysiology study
Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery.
Number of patients with supraventricular tachycardia
Number of days post-operatively at time of supraventricular tachycardia
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with adverse events related to provocative electrophysiology testing
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with sustained supraventricular tachycardia
Number of days post-operatively at time of sustained supraventricular tachycardia
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with other tachyarrhythmias
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively at time of extubation
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively in the intensive care unit
Time frame: Though hospital discharge
Number of days in the hospital
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with adverse events related to antiarrhythmic treatment
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with supraventricular tachycardia after hospital discharge
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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