- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768634
Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Audrey Dionne, MD
- Phone Number: 45094 6173552079
- Email: audrey.dionne@cardio.chboston.org
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Observation
Patients will be observed for arrhythmias and treated if they occur.
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|
Experimental: Testing
Patients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced.
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Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with supraventricular tachycardia
Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days
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Number of days post-operatively at time of supraventricular tachycardia
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Through hospital discharge after cardiac surgery, or up to 90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with adverse events related to provocative electrophysiology testing
Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days
|
Through hospital discharge after cardiac surgery, or up to 90 days
|
|
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
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Through hospital discharge after cardiac surgery, or up to 90 days
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Number of patients with other tachyarrhythmias
Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days
|
Through hospital discharge after cardiac surgery, or up to 90 days
|
|
Number of days post-operatively at time of extubation
Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days
|
Through hospital discharge after cardiac surgery, or up to 90 days
|
|
Number of days post-operatively in the intensive care unit
Time Frame: Though hospital discharge
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Though hospital discharge
|
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Number of days in the hospital
Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days
|
Through hospital discharge after cardiac surgery, or up to 90 days
|
|
Number of patients with adverse events related to antiarrhythmic treatment
Time Frame: Through hospital discharge after cardiac surgery, or up to 90 days
|
Through hospital discharge after cardiac surgery, or up to 90 days
|
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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
|
Through hospital discharge after cardiac surgery, or up to 90 days
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Number of patients with supraventricular tachycardia after hospital discharge
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Audrey Dionne, MD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00037574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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