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Clinical Trials/NCT01912326
NCT01912326
Completed
Not Applicable

Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Abbott Medical Devices1 site in 1 country249 target enrollmentJuly 2002
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ConditionsBradycardiaAtrial Fibrillation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bradycardia
Sponsor
Abbott Medical Devices
Enrollment
249
Locations
1
Primary Endpoint
Reduction of AT/AF Burden in the pacemaker diagnostics
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
July 2002
End Date
April 2008
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reduction of AT/AF Burden in the pacemaker diagnostics

Time Frame: 12 months

Study Sites (1)

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