I48
Conditions
Interventions
Group 1: Patients mit Biotronik device and a history or new onset of atrial fibrillation
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients with a BIOTRONIK dual-chamber ICD, DX, CRT-D, CRT-P, or pacemaker 2) Inclusion no earlier than 4 weeks after implantation 3) Patients's agreement to use CardioMessenger® and BIOTRONIK Home Monitoring® 4) Age = 18 years 1st group: Documented paroxysmal or persistent atrial fibrillation and increased NT-pro-BNP (> 125pg / ml) within the last 8 weeks 2nd group: Sinus rhythm and CHA2DS2VASc value = 4 or sinus rhythm and increased NT-proBNP (> 125pg / ml) within the last 8 weeks
Exclusion criteria
Exclusion criteria: 1. Life expectancy <1 year 2. Inability of the patient to complete the study protocol 3. Known alcohol or drug addiction 4. Participation in another interventional clinical study 5. Existing or currently planned pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the pilot study is to set up and evaluate an atrial fibrillation (AF) network with selected device data in combination with routine clinical data for data analysis - including analysis of the atrial fibrillation burden. The pilot study should first validate the AF burden measured value (variability / dynamics, determination of the AF burden range, stability of the AF range value). For the pilot study we plan to include 50 patients with previously or newly diagnosed atrial fibrillation; the study is plannefor three years. The patients are screened as part of the routine presentation in our device outpatient clinic. If the patients meet the inclusion and exclusion criteria and agree to participate in the study, the patients can be included by the responsible investigator. At the time of inclusion, clinical, laboratory chemical (proBNP) and echocardiographic parameters were collected in addition to the device parameters (see attached patient questionnaire). Both three and six months after inclusion in the study, the patients receive another device query as part of the routine examination and another questionnaire (see patient questionnaire follow-up attached). Clinical, laboratory chemical (proBNP) and echocardiographic parameters as well as changes in resilience/symptoms are compared again. | — |
Secondary
| Measure | Time frame |
|---|---|
| The atrial fibrillation burden should be correlated with clinically collected patient data such as quality of life, left venticel function, resilience, etc. In addition, proof of the feasibility of data logistics within the network (automated data streaming / home monitoring data) should be provided. In the long term, the study is planned to be expanded to 300 patients and the combined endpoint of hospitalization rate/all-cause mortality/cardiovascular mortality/TIA/stroke/ SEE should be recorded. | — |
Countries
Germany
Contacts
Public ContactNadine Vonderlin
Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie
Outcome results
None listed