REACTion on long episodes of atrial tachycardia detected with Lumax DX
- Conditions
- I47.2I49.8I48Atrial fibrillation and flutterOther specified cardiac arrhythmiasVentricular tachycardia
- Registration Number
- DRKS00010898
- Lead Sponsor
- BIOTRONIK SE & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 236
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
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Number of patients with atrial tachycardia (>6min, >190bpm)<br>- Number of patients with arrhythmic symptoms<br>- Medical reaction on the first ICD detected and documented event<br>- Time from occurence to treatment of atrial fibrillation<br>- Duration and number of atrial and ventricular episodes<br>- Quality and stability of all relevant system parameters<br>- History of PP-, PR- and RR-intervals before the onset of atrial and/or ventricular tachycardias<br>