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Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

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ClinicalTrials.gov Identifier: NCT04768634
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : August 2, 2021
Sponsor:
Collaborators:
American Heart Association
The Children's Heart Foundation
Information provided by (Responsible Party):
Audrey Dionne, Boston Children's Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Arrhythmia in Children Congenital Heart Disease Diagnostic Test: Provocative electrophysiology study Not Applicable

Detailed Description:
This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with supraventricular tachycardia [ Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days ]
    Number of days post-operatively at time of supraventricular tachycardia


Secondary Outcome Measures :
  1. Number of patients with adverse events related to provocative electrophysiology testing [ Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days ]
  2. Number of patients with sustained supraventricular tachycardia [ Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days ]
    Number of days post-operatively at time of sustained supraventricular tachycardia

  3. Number of patients with other tachyarrhythmias [ Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days ]
  4. Number of days post-operatively at time of extubation [ Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days ]
  5. Number of days post-operatively in the intensive care unit [ Time Frame: Though hospital discharge ]
  6. Number of days in the hospital [ Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days ]
  7. Number of patients with adverse events related to antiarrhythmic treatment [ Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days ]
  8. 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 ]
  9. Number of patients with supraventricular tachycardia after hospital discharge [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768634


Contacts
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Contact: Audrey Dionne, MD 6173552079 ext 45094 audrey.dionne@cardio.chboston.org

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Audrey Dionne, MD         
Sponsors and Collaborators
Boston Children's Hospital
American Heart Association
The Children's Heart Foundation
Investigators
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Principal Investigator: Audrey Dionne, MD Boston Children's Hospital
More Information
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Responsible Party: Audrey Dionne, Pediatric Cardiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04768634    
Other Study ID Numbers: IRB-P00037574
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities