Tachyarrhythmia
Conditions
Keywords
Indication for cardiac pacing, Atrial Arrhythmia, Indication for the implantation of a pacemaker according to the German guidelines, Documented (ECG) atrial tachyarrhythmia within the last three months before enrollment
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.
Interventions
DEVICEActivation of preventive and therapeutic algorithms for treatment of AF
Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation
DEVICEAF Prevention and Therapy Algorithms On
Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Atrial fibrillation (AF)-burden | 2 years |
| Cost-efficiency | 2 years |
| Incidence in different pacing modes [AAI, DDD(R)] | 2 years |
| Evaluation of possible atrial proarrhythmic effects of the termination algorithms | 2 years |
| Time interval between persistent episodes during the follow-up period | 2 years |
Countries
Germany
Outcome results
None listed