Volunteers to Investigate Best Results for Ablation and Novel Therapies for Atrial Fibrillation
NCT ID: NCT05504356
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1125 participants
OBSERVATIONAL
2022-04-27
2027-07-31
Brief Summary
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* Identify clinically relevant predictors of effectiveness and complications of AF ablation procedures in a prospective, US-based, multi-center, real-world longitudinal study
* Assess changes in modifiable lifestyle-related exposures influence the effectiveness of AF ablation
* Determine incidence and predictors of complications of AF ablation procedures
Participants will connect with the Eureka Research Platform and answer a series of surveys and activities over a one-year period. They will be asked about lifestyle habits, recurrence of AFib, hospitalizations, and general feelings and emotions.
Detailed Description
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This is a longitudinal, observational cohort study. 15,000 subjects are planned to be enrolled, and will be followed for a period of one year. Subjects will be asked weekly survey questions on weekly habits, complications, medication usage, and hospitalizations. They will have the option to receive AliveCor Kardia devices for remote ECG monitoring, as well as connect their Apple HealthKit data. Surveys will be conducted via the Eureka mobile app.
In conjunction with the Eureka Research Platform, the study will leverage the AF Ablation National Cardiovascular Data Registry (NCDR) run by the American College of Cardiology (ACC). This rapidly growing registry includes comprehensive data regarding patient, procedure, and institution-level characteristics, now includes over 200 institutions around the US, and has already enrolled more than 47,000 patients. However, the registry is limited to data collected during the index procedure visit, without longitudinal follow-up or patient reported outcomes. The study will link the Eureka Research Platform data to NCDR registry data on the index procedure for a subset of participants, allowing for analysis of longitudinal follow-up together with index procedure data.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Must have a smartphone device (iOS and/or Android) and cell phone number to participate on the mobile app, and will be willing to download the Eureka Research Platform mobile application
* Must have email address to participate on the web portal (accessible on any web-connected device)
* Undergone a catheter ablation procedure for atrial fibrillation in the week prior to recruitment, or have an ablation planned for within a week from recruitment
Exclusion Criteria
* Unable to read, speak, comprehend English
18 Years
ALL
No
Sponsors
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American College of Cardiology
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Gregory Marcus, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Greg Marcus
Role: primary
Other Identifiers
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P0548846
Identifier Type: -
Identifier Source: org_study_id