Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Atrial Fibrillation Clinical Trial

— PAFOS  

Official title:

Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912326
• Other study ID #: B01- 408
• Status: Completed
• Phase: N/A
• Start date: July 2002
• Est. completion date: April 2008

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bradycardia

Intervention

Device:
• Pacemaker Implantation
Implantation of a dual chamber pacemaker

Locations

Country	Name	City	State
Germany	Universitätsklinikum Bonn AdöR	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of AT/AF Burden in the pacemaker diagnostics		12 months