Skip to main content
OpenTrials
Completed

NCT Number: NCT03549806

Stanford Cardiac Invasive Electrophysiology Novel Computer Experience

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Atrial Tachycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Hospital

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention. Test is computer algorithm.

Diagnostic Test

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

Primary outcomes

  1. Reduction in AF burden on follow-up

    Time frame: 2 years

    Reduction in amount of arrhythmia per unit time, compared to prior to the procedure.

  2. Freedom from arrhythmia on follow-up

    Time frame: 2 years

    Absence of arrhythmia, defined by clinical thresholds.

Secondary outcomes

  1. Clinical status as measured by the EQ5D

    Time frame: 2 years

    Patient feeling better subjectively in EQ5D

Other outcomes

  1. Acute Impact of Ablation

    Time frame: Day zero (that is, during procedure).

    Documentation of whether ablation acutely eliminated atrial fibrillation

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

Acronym: SCIENCE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2018
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.