Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

N/ACompletedNCT01912326

Abbott Medical Devices249 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

249

Conditions

Bradycardia Atrial Fibrillation

Interventions

Pacemaker ImplantationDEVICE

Implantation of a dual chamber pacemaker

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Bonn AdöR

Bonn, Germany

Outcomes

Primary Outcomes

Reduction of AT/AF Burden in the pacemaker diagnostics

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.