I48.1 I48.0
Conditions
Interventions
Group 1: Arm 1 (Intervention to Promote Physical Activity Using Wearables): An intervention primarily delivered remotely to support physical activity (PA) through: monitoring via wearables, regular fe
Sponsors
Universitätsklinikum Regensburg
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: Atrial fibrillation with an indication for pulmonary vein isolation, ability and motivation to engage in physical activity, informed consent.
Exclusion criteria
Exclusion criteria: Previous pulmonary vein isolation, valve-related atrial fibrillation, overt heart failure with a left ventricular ejection fraction of 10 hours/week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What: combined feasibility parameters (proportion of patients achieving PA targets, ratio of patients screened/randomized and randomized/analyzed). When: after the intervention phase (7 months). How: monitoring by wearable device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary feasibility objectives are to assess recruitment, randomization, retention, adherence to wearable monitoring, completeness of follow-up assessments, acceptability of the intervention, technical functionality of wearable data transfer, and safety of supported PA after AF ablation. Exploratory clinical and mechanistic objectives are to estimate the effect size and variability of the intervention on AF recurrence, AF burden, inflammatory biomarkers, cardiac structure and function, left atrial fibrosis, quality of life, and cardiovascular outcomes. | — |
Countries
Germany
Contacts
Public ContactChristian Schach
Universitätsklinik Regensburg
Outcome results
None listed