Clinical trial NCT04768634: Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Official title: Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arrhythmia in Children
Congenital Heart Disease
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: The Children's Heart Foundation
First posted: 2021-02-24
Enrollment: 46
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management

Eligibility criteria: Inclusion Criteria:

* Patients aged \< 18 years of age on admission to the cardiac intensive care unit following cardiac surgery with a predicted probability of supraventricular tachycardia \>10%

Exclusion Criteria:

* Patients following orthotopic heart transplant, ventricular assist device implantation, primary extracorporeal membrane oxygenation cannulation, pacemaker or implantable cardioverter-defibrillator implantation or sympathectomy
* Patients on antiarrhythmic medication at the time of surgery
* Patients with atrioventricular conduction disease (1st degree atrioventricular block with PR interval greater than 200 ms, 2nd degree atrioventricular block or complete heart block)
* Patients with severe ventricular dysfunction in whom therapy with beta-blocker or sotalol is deemed contra-indicated by the primary team
* Patients with absent or non-functioning atrial pacing wires

Primary outcomes:
measure: Number of patients with supraventricular tachycardia
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
Secondary outcomes:
measure: Number of patients with adverse events related to provocative electrophysiology testing
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
measure: Number of patients with sustained supraventricular tachycardia
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
measure: Number of patients with other tachyarrhythmias
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
measure: Number of days post-operatively at time of extubation
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
measure: Number of days post-operatively in the intensive care unit
timeFrame: Though hospital discharge
measure: Number of days in the hospital
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
measure: Number of patients with adverse events related to antiarrhythmic treatment
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
measure: Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)
timeFrame: Through hospital discharge after cardiac surgery, or up to 90 days
measure: Number of patients with supraventricular tachycardia after hospital discharge
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Audrey Dionne, MD
role: PRINCIPAL_INVESTIGATOR
References: