Stanford Cardiac Invasive Electrophysiology Novel Computer Experience

Completed

• Conditions: Atrial Tachycardia; Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac
• Interventions: Diagnostic Test: No Intervention. Test is computer algorithm.

• Registration Number: NCT03549806
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-08
• Study Start: 2018-06-21
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Patients undergoing catheter ablation for atrial arrhythmias

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	No Intervention. Test is computer algorithm.	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical status as measured by the EQ5D	2 years	Patient feeling better subjectively in EQ5D

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Stanford, California, United States