Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

NCT04768634 | Terminated DMC

• 1 other identifier: IRB-P00037574
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmia in Children; Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  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

Study Arms (2)

Observation

NO INTERVENTION

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

Testing

EXPERIMENTAL

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

Diagnostic Test: Provocative electrophysiology study

Interventions

Provocative electrophysiology study DIAGNOSTIC_TEST

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

Testing

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• American Heart Association: collaborator
• The Children's Heart Foundation: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Audrey Dionne, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiologist

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 24, 2021
• Study Start: March 23, 2021
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)