Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Not Applicable

Completed

• Conditions: Bradycardia; Atrial Fibrillation
• Interventions: Device: Pacemaker Implantation

• Registration Number: NCT01912326
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AF Suppression On	Pacemaker Implantation	AF Suppression Algorithm On, optimized AF Pacemaker Programming
AF Suppression Off	Pacemaker Implantation	AF Suppression programmed Off, Optimized Pacemaker Programming

Primary Outcome Measures

Name	Time	Method
Reduction of AT/AF Burden in the pacemaker diagnostics	12 months

Trial Locations

Locations (1)

Universitätsklinikum Bonn AdöR; 🇩🇪 Bonn, Germany