Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing

NCT ID: NCT01803217

Last Updated: 2017-04-10

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2016-06-30

Brief Summary

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Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators.

The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

Detailed Description

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Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.

Conditions

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Pacemaker Implantation for Sinus Node Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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mode switch to atrial pacing

Group Type EXPERIMENTAL

pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

Intervention Type OTHER

atrioventricular hysteresis function

Group Type ACTIVE_COMPARATOR

pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

Intervention Type OTHER

Interventions

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pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Indication for the implantation of a dual-chamber pacemaker

Exclusion Criteria

Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum Bamberg

OTHER

Sponsor Role collaborator

Krankenhaus Peißenberg

UNKNOWN

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Bamberg

Bamberg, Bavaria, Germany

Site Status

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

München, Bavaria, Germany

Site Status

Krankenhaus Peißenberg

Peißenberg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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GER-EP-010

Identifier Type: -

Identifier Source: org_study_id

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