APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias

Study Overview
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Brief Summary
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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.

Official Title
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Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing

Conditions
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Tachyarrhythmia

Intervention / Treatment
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* Device: Activation of preventive and therapeutic algorithms for treatment of AF
* Device: AF Prevention and Therapy Algorithms On


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Algorithms for prevention and termination of AF not activated | |
| Active Comparator: Prevention and Therapy Algorithms on<br>Activation of preventive and therapeutic algorithms | Device: Activation of preventive and therapeutic algorithms for treatment of AF<br>* Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation<br>Device: AF Prevention and Therapy Algorithms On<br>* Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Evaluation of possible atrial proarrhythmic effects of the termination algorithms |  | 2 years | 
| Cost-efficiency |  | 2 years | 
| Incidence in different pacing modes [AAI, DDD(R)] |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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