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

Not Applicable

Completed

• Conditions: Tachyarrhythmia
• Interventions: Device: Activation of preventive and therapeutic algorithms for treatment of AF; Device: AF Prevention and Therapy Algorithms On

• Registration Number: NCT00170274
• Lead Sponsor: Medtronic Bakken Research Center

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

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2011-06
• Study Completion: 2014-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-30

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

Arm && Interventions

Group	Intervention	Description
Prevention and Therapy Algorithms on	Activation of preventive and therapeutic algorithms for treatment of AF	Activation of preventive and therapeutic algorithms
Prevention and Therapy Algorithms on	AF Prevention and Therapy Algorithms On	Activation of preventive and therapeutic algorithms

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
Evaluation of possible atrial proarrhythmic effects of the termination algorithms	2 years
Cost-efficiency	2 years
Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II	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
Incidence in different pacing modes [AAI, DDD(R)]	2 years

Trial Locations

Locations (6)

Klinikum der Stadt Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Germany

Krankenhaus Marienhof; 🇩🇪 Koblenz, Germany

Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen; 🇩🇪 Essen, Germany

Universitätsklinik Mannheim; 🇩🇪 Mannheim, Germany