Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation (PAFOS)

October 4, 2024 updated by: Abbott Medical Devices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn AdöR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AF Suppression On
AF Suppression Algorithm On, optimized AF Pacemaker Programming
Device: Pacemaker Implantation
Implantation of a dual chamber pacemaker
Other Names:
  • Pacemaker St. Jude Medical Identity DR Model 5370 or 5376
Active Comparator: AF Suppression Off
AF Suppression programmed Off, Optimized Pacemaker Programming
Device: Pacemaker Implantation
Implantation of a dual chamber pacemaker
Other Names:
  • Pacemaker St. Jude Medical Identity DR Model 5370 or 5376

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of AT/AF Burden in the pacemaker diagnostics
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimated)

July 31, 2013

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B01- 408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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