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.|
|ClinicalTrials.gov Identifier: NCT03549806|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Atrial Tachycardia Atrial Flutter Arrhythmias, Cardiac||Diagnostic Test: No Intervention. Test is computer algorithm.|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
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
- 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.
- Freedom from arrhythmia on follow-up [ Time Frame: 2 years ]Absence of arrhythmia, defined by clinical thresholds.
- Clinical status as measured by the EQ5D [ Time Frame: 2 years ]Patient feeling better subjectively in EQ5D
- Acute Impact of Ablation [ Time Frame: Day zero (that is, during procedure). ]Documentation of whether ablation acutely eliminated atrial fibrillation
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
|Contact: Sanjiv M Narayan, MD, PhD||(650) firstname.lastname@example.org|
|Contact: Kathleen Mills, BAemail@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Kathleen Mills, BA firstname.lastname@example.org|
|Contact: Sanjiv Narayan, MD, PhD|
|Principal Investigator:||Sanjiv Narayan, MD, PhD||Stanford University|