APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
Not Applicable
Completed
- Conditions
- Tachyarrhythmia
- Registration Number
- NCT00170274
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to the German guidelines. Medication is controlled throughout the study with a beta-blocker as the only antiarrhythmic drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
- Indication for cardiac pacing according to the German guidelines
- Documented (electrocardiogram; ECG) atrial arrhythmia during the last three months before enrollment
- Willingness to terminate antiarrhythmic drugs until the first recurrence of an atrial arrhythmia
- Sinus rhythm during 24 hours before implant of the device
Exclusion Criteria
- Ejection fraction below 40%
- Mechanic prosthesis of the tricuspid valve
- Indication to implantable cardioverter defibrillator (ICD)-implantation
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias 2 years Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia 2 years
- Secondary Outcome Measures
Name Time Method Atrial fibrillation (AF)-burden 2 years Time interval between persistent episodes during the follow-up period 2 years Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device 2 years Quality of life 2 years Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II 2 years Incidence in different pacing modes [AAI, DDD(R)] 2 years Evaluation of possible atrial proarrhythmic effects of the termination algorithms 2 years Cost-efficiency 2 years
Trial Locations
- Locations (6)
Segeberger Kliniken
🇩🇪Bad Segeberg, Germany
Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen
🇩🇪Essen, Germany
Krankenhaus Marienhof
🇩🇪Koblenz, Germany
Klinikum der Stadt Ludwigshafen
🇩🇪Ludwigshafen, Germany
Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Universitätsklinik Mannheim
🇩🇪Mannheim, Germany
Segeberger Kliniken🇩🇪Bad Segeberg, Germany