Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

Boston Children's Hospital

Status: Terminated

Conditions: Arrhythmia in Children; Congenital Heart Disease

Treatments: Diagnostic Test: Provocative electrophysiology study

Study type: Interventional

Funder types: Other

Identifiers

NCT04768634

IRB-P00037574

Details and patient eligibility

About

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.

Full description

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

Enrollment: 46 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Observation

No Intervention group

Description:

Patients will be observed for arrhythmias and treated if they occur.

Testing

Experimental group

Description:

Patients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced.

Treatment:

Diagnostic Test: Provocative electrophysiology study