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Completed

NCT Number: NCT00170274

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

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.

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Segeberger Kliniken, Bad Segeberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activation of preventive and therapeutic algorithms for treatment of AF

Device

Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation

AF Prevention and Therapy Algorithms On

Device

Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm

Primary outcomes

  1. Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias

    Time frame: 2 years

  2. Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia

    Time frame: 2 years

Secondary outcomes

  1. Atrial fibrillation (AF)-burden

    Time frame: 2 years

  2. Time interval between persistent episodes during the follow-up period

    Time frame: 2 years

  3. Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device

    Time frame: 2 years

  4. Quality of life

    Time frame: 2 years

  5. Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II

    Time frame: 2 years

  6. Evaluation of possible atrial proarrhythmic effects of the termination algorithms

    Time frame: 2 years

  7. Cost-efficiency

    Time frame: 2 years

  8. Incidence in different pacing modes [AAI, DDD(R)]

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2011
Study completion
2014
First posted
Sep 15, 2005
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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