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

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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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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