Viewing Study NCT04768634


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Ignite Modification Date: 2025-12-26 @ 12:50 AM
Study NCT ID: NCT04768634
Status: TERMINATED
Last Update Posted: 2024-02-07
First Post: 2021-02-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Sponsor: Boston Children's Hospital
Organization:

Study Overview

Official Title: Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Status: TERMINATED
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: limited enrollment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: