Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

Congenital Heart Disease Clinical Trial

Official title:

Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04768634
• Other study ID #: IRB-P00037574
• Status: Terminated
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: February 6, 2024

Study information

• Verified date: February 2024
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: February 6, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia in Children
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	American Heart Association, The Children's Heart Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with supraventricular tachycardia	Number of days post-operatively at time of supraventricular tachycardia	Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of patients with adverse events related to provocative electrophysiology testing		Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of patients with sustained supraventricular tachycardia	Number of days post-operatively at time of sustained supraventricular tachycardia	Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of patients with other tachyarrhythmias		Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of days post-operatively at time of extubation		Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of days post-operatively in the intensive care unit		Though hospital discharge
Secondary	Number of days in the hospital		Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of patients with adverse events related to antiarrhythmic treatment		Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)		Through hospital discharge after cardiac surgery, or up to 90 days
Secondary	Number of patients with supraventricular tachycardia after hospital discharge		12 months