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Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

Primary Purpose

Arrhythmia in Children, Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provocative electrophysiology study
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmia in Children

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation

Testing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of patients with supraventricular tachycardia
Number of days post-operatively at time of supraventricular tachycardia

Secondary Outcome Measures

Number of patients with adverse events related to provocative electrophysiology testing
Number of patients with sustained supraventricular tachycardia
Number of days post-operatively at time of sustained supraventricular tachycardia
Number of patients with other tachyarrhythmias
Number of days post-operatively at time of extubation
Number of days post-operatively in the intensive care unit
Number of days in the hospital
Number of patients with adverse events related to antiarrhythmic treatment
Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)
Number of patients with supraventricular tachycardia after hospital discharge

Full Information

First Posted
February 8, 2021
Last Updated
September 7, 2022
Sponsor
Boston Children's Hospital
Collaborators
American Heart Association, The Children's Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04768634
Brief Title
Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Official Title
Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
American Heart Association, The Children's Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia in Children, Congenital Heart Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
No Intervention
Arm Description
Patients will be observed for arrhythmias and treated if they occur.
Arm Title
Testing
Arm Type
Experimental
Arm Description
Patients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced.
Intervention Type
Diagnostic Test
Intervention Name(s)
Provocative electrophysiology study
Intervention Description
Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery.
Primary Outcome Measure Information:
Title
Number of patients with supraventricular tachycardia
Description
Number of days post-operatively at time of supraventricular tachycardia
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Secondary Outcome Measure Information:
Title
Number of patients with adverse events related to provocative electrophysiology testing
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Title
Number of patients with sustained supraventricular tachycardia
Description
Number of days post-operatively at time of sustained supraventricular tachycardia
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Title
Number of patients with other tachyarrhythmias
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Title
Number of days post-operatively at time of extubation
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Title
Number of days post-operatively in the intensive care unit
Time Frame
Though hospital discharge
Title
Number of days in the hospital
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Title
Number of patients with adverse events related to antiarrhythmic treatment
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Title
Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)
Time Frame
Through hospital discharge after cardiac surgery, or up to 90 days
Title
Number of patients with supraventricular tachycardia after hospital discharge
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Dionne, MD
Phone
6173552079
Ext
45094
Email
audrey.dionne@cardio.chboston.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Dionne, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Dionne, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

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