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Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation (PAFOS)

Primary Purpose

Bradycardia, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pacemaker Implantation
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bradycardia focused on measuring pacemaker, atrial fibrillation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Bonn AdöR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AF Suppression On

AF Suppression Off

Arm Description

AF Suppression Algorithm On, optimized AF Pacemaker Programming

AF Suppression programmed Off, Optimized Pacemaker Programming

Outcomes

Primary Outcome Measures

Reduction of AT/AF Burden in the pacemaker diagnostics

Secondary Outcome Measures

Full Information

First Posted
July 26, 2013
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01912326
Brief Title
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Acronym
PAFOS
Official Title
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Atrial Fibrillation
Keywords
pacemaker, atrial fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AF Suppression On
Arm Type
Active Comparator
Arm Description
AF Suppression Algorithm On, optimized AF Pacemaker Programming
Arm Title
AF Suppression Off
Arm Type
Active Comparator
Arm Description
AF Suppression programmed Off, Optimized Pacemaker Programming
Intervention Type
Device
Intervention Name(s)
Pacemaker Implantation
Other Intervention Name(s)
Pacemaker St. Jude Medical Identity DR Model 5370 or 5376
Intervention Description
Implantation of a dual chamber pacemaker
Primary Outcome Measure Information:
Title
Reduction of AT/AF Burden in the pacemaker diagnostics
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Universitätsklinikum Bonn AdöR
City
Bonn
ZIP/Postal Code
53127
Country
Germany

12. IPD Sharing Statement

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Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

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