Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

NCT ID: NCT01912326

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2008-04-30

Brief Summary

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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

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

Conditions

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Bradycardia Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AF Suppression On

AF Suppression Algorithm On, optimized AF Pacemaker Programming

Group Type ACTIVE_COMPARATOR

Pacemaker Implantation

Intervention Type DEVICE

Implantation of a dual chamber pacemaker

AF Suppression Off

AF Suppression programmed Off, Optimized Pacemaker Programming

Group Type ACTIVE_COMPARATOR

Pacemaker Implantation

Intervention Type DEVICE

Implantation of a dual chamber pacemaker

Interventions

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Pacemaker Implantation

Implantation of a dual chamber pacemaker

Intervention Type DEVICE

Other Intervention Names

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Pacemaker St. Jude Medical Identity DR Model 5370 or 5376

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Bonn AdöR

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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B01- 408

Identifier Type: -

Identifier Source: org_study_id

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