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

Medtronic

Status: Completed

Conditions: Tachyarrhythmia

Treatments: Device: AF Prevention and Therapy Algorithms On; Device: Activation of preventive and therapeutic algorithms for treatment of AF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00170274

CEN_G_CA_5

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Algorithms for prevention and termination of AF not activated

Prevention and Therapy Algorithms on

Active Comparator group

Description:

Activation of preventive and therapeutic algorithms

Treatment:

Device: Activation of preventive and therapeutic algorithms for treatment of AF

Device: AF Prevention and Therapy Algorithms On