N/A N=499 Randomized Treatment

Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation

Atrial Fibrillation Paroxysmal

Bottom Line

View on ClinicalTrials.gov: NCT03323099 ↗

Enrolled (actual)

499

Serious AEs

4.8%

Results posted

Nov 2023

Primary outcome: Primary: Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) — 1.7; 0.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: N-of-1 (Behavioral); Data Tracking (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)	1.7; 0.5	—

Summary

The I-STOP-Afib study will test the comparative effectiveness of using N-of-1 trials vs. symptom surveillance alone to reduce Atrial Fibrillation (AF) episode frequency and severity and improve quality of life for AF patients. The study will involve randomizing almost 500 paroxysmal AF patients to either AF episode tracking versus engaging in testing the relationship between participant-selected triggers and AF episodes utilizing a mobile-app based N-of-1 study design. Both groups will complete a validated survey to assess AF severity, essentially a measure of quality of life while living with AF, before and after a 3 month testing period.

Eligibility Criteria

Inclusion Criteria

symptomatic paroxysmal AF
a smartphone

Exclusion Criteria

Non-English speakers
Children (age < 18 years)
Patients with plans to substantially change AF management (such as with ablation or change in antiarrhythmic drugs) over the ensuing 6 months
Unwillingness to test AF triggers.
Patients who have had an AV node or AV Junction ablation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03323099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.