I48 I49.8 I47.2
Conditions
Interventions
Group 1: Every patient will be implanted with an ICD for primary or secondary prevention. Each patient will get two longterm ECGs. Every patient has to answer EQ-5D-3L questionaire twice.
Sponsors
BIOTRONIK SE & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with standard ICD indication according to guidelines - Patient has an implanted Lumax 740 VR-T DX (or successor) - Usage of Home Monitoring Service Center - Availability of patient for follow-up visits on a regular basis according to Clinical Investigation Plan - Patient has signed informed consent form - Sufficient coverage of mobile phone network
Exclusion criteria
Exclusion criteria: - Patients with permanent atrial fibrillation - Indication for cardiac resynchronization therapy - Life expectancy of less than six months - Expected cardiac surgery within 6 months after enrollment - Age under 18 years - Enrolled in another cardiac clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main aim of the registry is to investigate the effect of different standard therapies to episodes of atrial tachycardia (duration above 6 minutes at a frequency above 190 beats per minute). Atrial Episodes are continously detecetd and stored by the implanted device. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of patients with atrial tachycardia (>6min, >190bpm) - Number of patients with arrhythmic symptoms - Medical reaction on the first ICD detected and documented event - Time from occurence to treatment of atrial fibrillation - Duration and number of atrial and ventricular episodes - Quality and stability of all relevant system parameters - History of PP-, PR- and RR-intervals before the onset of atrial and/or ventricular tachycardias | — |
Countries
Germany
Contacts
Public ContactAlexander Schirdewan
SANA Klinikum Lichtenberg
Outcome results
None listed