Atrial Fibrillation, Risk of Cardiac Arrhythmias
Conditions
Keywords
Atrial Fibrillation, Risk of cardiac arrhythmias, Loop recorder
Brief summary
The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety.
Detailed description
The study is a prospective, non-randomized, multi-center international post-market study. The study will be conducted at 20-30 centers primarily in Europe. The study will be conducted at least in Germany, Austria, Switzerland, The Netherlands, and the Czech Republic. Study centers from Canada may also participate, depending on the timelines for regulatory approval and commercial release of the Reveal® XT in this region. It is expected that between 140 and 200 patients will be enrolled to ensure that at least 47 patients are included to assess the first primary objective and at least 60 patients to assess the second primary objective. The primary objective is to quantify the AF detection performance of the device. The patient population will be assessed in two separate cohorts. The first primary objective is to quantify the 24-hour AF burden accuracy in patients with more than 1% AF burden. The second primary objective is to quantify the detection accuracy of non-arrhythmia in patients with 1% or less AF burden.
Interventions
OTHER46 hrs Holter ECG recording
Maximum of 2 46 hrs external Holter ECG recordings are required.
Sponsors
Medtronic BRC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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 |
|---|---|
| Atrial Fibrillation Burden (AF Burden) | 46 hrs |
Secondary
| Measure | Time frame |
|---|---|
| AF episode detection accuracy and AF episode duration accuracy | 46 hrs |
Countries
Austria, Belgium, Canada, Czechia, Germany, Netherlands, Russia, Slovakia
Outcome results
None listed