AF detection algoritm
Conditions
Interventions
None listed
Sponsors
Medtronic SQDM
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patient is willing and able to provide his/her informed consent • Patient has been implanted with a Reveal® XT • Patient fulfills at least one of the following three additional requirements 1. is scheduled for PV ablation or surgical rhythm control intervention, and the PV ablation or surgical intervention can be deferred until study completion or 2. has documented frequent AF or frequent symptoms attributable to AF or 3. has undergone PV ablation within the last 6 months and still has symptoms attributable to AF
Exclusion criteria
Exclusion criteria: - Patient has an implanted pacemaker or ICD - Patient has persistent or permanent AF - Patient is allergic to adhesive ECG electrodes - The study will interfere with a therapeutic or diagnostic procedure which is planned or expected during the study period - Patient is participating in another study that is expected to compromise the results of this study - Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study - Patient is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is: - the AF burden determined from the subcutaneous ECG. Secondary endpoints are: - R-wave sensing performance parameters, AF performance parameters, and adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - R-wave sensing performance parameters, - AF performance parameters, - and adverse events. | — |
Countries
Netherlands
Outcome results
None listed