Status:
TERMINATED
Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
American Heart Association
The Children's Heart Foundation
Conditions:
Arrhythmia in Children
Congenital Heart Disease
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 afte...
Detailed Description
This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04768634
Start Date
March 23 2021
End Date
February 6 2024
Last Update
February 7 2024
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115