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limited enrollment
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| The Children's Heart Foundation | OTHER |
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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.
This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | No Intervention | Patients will be observed for arrhythmias and treated if they occur. | |
| Testing | Experimental | Patients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provocative electrophysiology study | Diagnostic Test | Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with supraventricular tachycardia | Number of days post-operatively at time of supraventricular tachycardia | Through hospital discharge after cardiac surgery, or up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events related to provocative electrophysiology testing | Through hospital discharge after cardiac surgery, or up to 90 days | |
| Number of patients with sustained supraventricular tachycardia | Number of days post-operatively at time of sustained supraventricular tachycardia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audrey Dionne, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Through hospital discharge after cardiac surgery, or up to 90 days |
| Number of patients with other tachyarrhythmias | Through hospital discharge after cardiac surgery, or up to 90 days |
| Number of days post-operatively at time of extubation | Through hospital discharge after cardiac surgery, or up to 90 days |
| Number of days post-operatively in the intensive care unit | Though hospital discharge |
| Number of days in the hospital | Through hospital discharge after cardiac surgery, or up to 90 days |
| Number of patients with adverse events related to antiarrhythmic treatment | Through hospital discharge after cardiac surgery, or up to 90 days |
| Number of patients with major adverse cardiac events (including need for CPR, ECMO or death) | Through hospital discharge after cardiac surgery, or up to 90 days |
| Number of patients with supraventricular tachycardia after hospital discharge | 12 months |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |