Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

May 4, 2021 updated by: Sanjiv Narayan, MD, PhD, Stanford University

Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

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

Study Overview

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
Freedom from arrhythmia on follow-up
Time Frame: 2 years
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
Time Frame: 2 years
Patient feeling better subjectively in EQ5D
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Impact of Ablation
Time Frame: Day zero (that is, during procedure).
Documentation of whether ablation acutely eliminated atrial fibrillation
Day zero (that is, during procedure).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2018

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

January 11, 2021

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on No Intervention. Test is computer algorithm.

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