Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease; Arrhythmia in Children
• Intervention / Treatment: Diagnostic test: Provocative electrophysiology study

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation; Patients will be observed for arrhythmias and treated if they occur.
Experimental: Testing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events related to provocative electrophysiology testing		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	Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with other tachyarrhythmias		Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively at time of extubation		Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively in the intensive care unit		Though hospital discharge
Number of days in the hospital		Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with adverse events related to antiarrhythmic treatment		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)		Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with supraventricular tachycardia after hospital discharge		12 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: American Heart Association; The Children's Heart Foundation
• Investigators: Principal Investigator: Audrey Dionne, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): February 6, 2024

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: IRB-P00037574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No