Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

Stanford University

Status: Completed

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

Treatments: Diagnostic Test: No Intervention. Test is computer algorithm.

Study type: Observational

Funder types: Other

Identifiers

NCT03549806

SCIENCE

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

11 participants in 1 patient group

Prospective Cohort

Description:

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.

Treatment:

Diagnostic Test: No Intervention. Test is computer algorithm.