- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03549806
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
Status
Completed
Intervention / Treatment
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
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California
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Stanford, California, United States, 94305
- Stanford Hospital
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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.
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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
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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
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Reduction in amount of arrhythmia per unit time, compared to prior to the procedure.
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2 years
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Freedom from arrhythmia on follow-up
Time Frame: 2 years
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Absence of arrhythmia, defined by clinical thresholds.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical status as measured by the EQ5D
Time Frame: 2 years
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Patient feeling better subjectively in EQ5D
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2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Impact of Ablation
Time Frame: Day zero (that is, during procedure).
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Documentation of whether ablation acutely eliminated atrial fibrillation
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Day zero (that is, during procedure).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- Alhusseini M, Vidmar D, Meckler GL, Kowalewski CA, Shenasa F, Wang PJ, Narayan SM, Rappel WJ. Two Independent Mapping Techniques Identify Rotational Activity Patterns at Sites of Local Termination During Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2017 Jun;28(6):615-622. doi: 10.1111/jce.13177. Epub 2017 Mar 20.
- Zaman JAB, Sauer WH, Alhusseini MI, Baykaner T, Borne RT, Kowalewski CAB, Busch S, Zei PC, Park S, Viswanathan MN, Wang PJ, Brachmann J, Krummen DE, Miller JM, Rappel WJ, Narayan SM, Peters NS. Identification and Characterization of Sites Where Persistent Atrial Fibrillation Is Terminated by Localized Ablation. Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005258. doi: 10.1161/CIRCEP.117.005258.
- Sahli Costabal F, Zaman JAB, Kuhl E, Narayan SM. Interpreting Activation Mapping of Atrial Fibrillation: A Hybrid Computational/Physiological Study. Ann Biomed Eng. 2018 Feb;46(2):257-269. doi: 10.1007/s10439-017-1969-3. Epub 2017 Dec 6.
- Navara R, Leef G, Shenasa F, Kowalewski C, Rogers AJ, Meckler G, Zaman JAB, Baykaner T, Park S, Turakhia MP, Zei P, Viswanathan M, Wang PJ, Narayan SM. Independent mapping methods reveal rotational activation near pulmonary veins where atrial fibrillation terminates before pulmonary vein isolation. J Cardiovasc Electrophysiol. 2018 May;29(5):687-695. doi: 10.1111/jce.13446. Epub 2018 Feb 22.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCIENCE
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.
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