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OpenTrials
Completed

NCT Number: NCT01912326

Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.

Hypothesis:

Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Bonn AdöR

Bonn, 53127, Germany

About this study

Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • indication for dual chamber pacemaker
  • documented paroxysmal or persistent Atrial Fibrillation
  • P-wave >1.0 mV in Sinus Rhythm or sufficient detection of AFib
  • stable antyarrhythmic therapy
  • age >= 19 years
  • written informed consent
  • implantation of a Identity DR 5370/5376 or later
  • bipolar atrial lead

Exclusion criteria

  • permanent AFib
  • reversible etiology of AFib
  • HYHA II or IV
  • Coronary Artery disease with stable angina pectoris
  • implanted ICD or planned implantation of a ICD
  • cardiac surgery within the last 6 months or planned within 12 months
  • live expectancy < 12 months
  • pregnancy

Treatment and study plan

Pacemaker implantation

Device

Implantation of a dual chamber pacemaker

Other names: Pacemaker St. Jude Medical Identity DR Model 5370 or 5376

Primary outcomes

  1. Reduction of AT/AF Burden in the pacemaker diagnostics

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: PAFOS

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Jul 31, 2013
Registry last updated
Oct 8, 2024

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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