COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03549806
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Sanjiv Narayan, MD, PhD, Stanford University

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

Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Tachycardia Atrial Flutter Arrhythmias, Cardiac Diagnostic Test: No Intervention. Test is computer algorithm.

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
Prospective Cohort
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.
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 Outcome Measures :
  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 Outcome Measures :
  1. Clinical status as measured by the EQ5D [ Time Frame: 2 years ]
    Patient feeling better subjectively in EQ5D

Other Outcome Measures:
  1. Acute Impact of Ablation [ Time Frame: Day zero (that is, during procedure). ]
    Documentation of whether ablation acutely eliminated atrial fibrillation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing clinically prescribed ablation for complex atrial arrhythmias will be approached for enrollment. Most are anticipated to be atrial fibrillation or atrial tachyarrhythmias such as post-ablation flutter. Men and women over 21 years and up to 80 years of age will be included.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03549806

Layout table for location contacts
Contact: Sanjiv M Narayan, MD, PhD (650) 723-9363
Contact: Kathleen Mills, BA

Layout table for location information
United States, California
Stanford Hospital Recruiting
Stanford, California, United States, 94305
Contact: Kathleen Mills, BA   
Contact: Sanjiv Narayan, MD, PhD         
Sponsors and Collaborators
Stanford University
Layout table for investigator information
Principal Investigator: Sanjiv Narayan, MD, PhD Stanford University
Publications of Results:
Layout table for additonal information
Responsible Party: Sanjiv Narayan, MD, PhD, Professor of Medicine (CV Medicine), Stanford University Identifier: NCT03549806    
Other Study ID Numbers: SCIENCE
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanjiv Narayan, MD, PhD, Stanford University:
Atrium, tachyarrhythmias
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Atrial Flutter
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease