Stanford Cardiac Invasive Electrophysiology Novel Computer Experience

Study Overview
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Brief Summary
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This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.

Detailed Description
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Patients will be recruited prospectively from among those undergoing ablation for atrial fibrillation (AF) or atrial tachycardias (AT) which may be reentrant or focal. Each patient will undergo careful data collection, including electrogram data and sites of ablation lesions. Ablation will proceed in operator-dependent fashion, and will not be modified in any way for this study. The research question is whether algorithms based on data such as electrograms and details of the ablation performed can predict which patients will have a successful case. Primary endpoints are measures of clinical success defined by (a) acute termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia burden; (c) long-term freedom from arrhythmia. Secondary endpoints include (a) identification of sites of arrhythmia termination; (b) improved clinical status.

Official Title
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Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

Conditions
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Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter, Arrhythmias, Cardiac

Intervention / Treatment
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* Diagnostic Test: No Intervention. Test is computer algorithm.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing catheter ablation for atrial arrhythmias Exclusion Criteria: Inability to sign informed consent Expected survival < 1 year Extreme comorbidity, such as advanced NYHA Class III/IV heart failure, dialysis, series stroke.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Cohort<br>No study intervention. Patients referred for ablation of atrial arrhythmias will be treated as per operator preference with no study intervention. Data will be collected in de-identified fashion. | Diagnostic Test: No Intervention. Test is computer algorithm.<br>* Diagnostic algorithms (test) will be run on already acquired clinical data. No study intervention in operator-prescribed clinical ablation. Predictive accuracy of test for study outcome will then be determined in follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in AF burden on follow-up | Reduction in amount of arrhythmia per unit time, compared to prior to the procedure. | 2 years | 
| Freedom from arrhythmia on follow-up | Absence of arrhythmia, defined by clinical thresholds. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status as measured by the EQ5D | Patient feeling better subjectively in EQ5D | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrium, tachyarrhythmias