Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

NCT ID: NCT04768634

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2024-02-06

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

Conditions

Arrhythmia in Children; Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Observation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Testing

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

Group Type: EXPERIMENTAL

Provocative electrophysiology study

Intervention Type: DIAGNOSTIC_TEST

Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery.

Interventions

Provocative electrophysiology study

Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

The Children's Heart Foundation

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Audrey Dionne

Pediatric Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Audrey Dionne, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00037574

Identifier Type: -

Identifier Source: org_study_id