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Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

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ClinicalTrials.gov Identifier: NCT03549806
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : July 2, 2018
Sponsor:
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.

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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


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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03549806


Contacts
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Contact: Sanjiv M Narayan, MD, PhD (650) 723-9363 sanjiv1@stanford.edu
Contact: Kathleen Mills, BA kmills2@stanford.edu

Locations
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United States, California
Stanford Hospital Recruiting
Stanford, California, United States, 94305
Contact: Kathleen Mills, BA       kmills2@stanford.edu   
Contact: Sanjiv Narayan, MD, PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sanjiv Narayan, MD, PhD Stanford University

Publications of Results:
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Responsible Party: Sanjiv Narayan, MD, PhD, Professor of Medicine (CV Medicine), Stanford University
ClinicalTrials.gov Identifier: NCT03549806     History of Changes
Other Study ID Numbers: SCIENCE
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Atrial Fibrillation
Tachycardia
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease