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Sponsors and Collaborators: |
Medtronic - Vitatron Vitatron GmbH |
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Information provided by: | Medtronic - Vitatron |
ClinicalTrials.gov Identifier: | NCT00161551 |
The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).
Condition | Intervention | Phase |
---|---|---|
Sick Sinus Syndrome |
Device: Vitatron T70 DR |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Prospective Multicenter Study to Determine the Incidence of Atrial Fibrillation and Heart Failure in Correlation to Stimulation Modes of Pacemakers |
Estimated Enrollment: | 402 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | December 2010 |
Background: Dual-chamber pacemaker therapy has become the mainstay for treating symptomatic sick sinus syndrome (SSS). This approach aims to results in a physiologic conduction pattern, while protecting against atrioventricular conduction anomalies. Smaller studies and subgroup analyses of larger trials suggest that ventricular stimulation associated with this treatment has adverse effects, especially an increased incidence of atrial fibrillation and heart failure.
Methods: In MODEST, a study on patients with sick sinus syndrome who have an indication for pacing therapy, atrial pacing (AAI) is compared with dual-chamber pacing (DDD) combined with a novel algorithm developed to lower the number of ventricularly paced beats. The study aims to assess the impact of ventricular pacing on the development of atrial arrhythmias and to test the hypothesis that DDD pacing using the algorithm is associated with a higher rate of atrial arrhythmias as atrial pacing. Included will be patients with SSS and no high degree AV node disease except for patients with first-degree AV block ≤300ms. Patients will be followed stratified by their Wenckebach point (≥ 120 bpm versus < 120 bpm).
Conclusion: MODEST is a large, prospective, randomized, multicenter trial aiming to compare a novel type of dual-chamber pacing approach (that includes an algorithm designed to lower the number of ventricularly paced beats) with pure atrial pacing, assessing the impact on the incidence of atrial arrhythmias in patients with sick sinus syndrome.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Matthias Reimers, Dipl. Documentalist | +49 21152930 | Matthias.reimers@vitatron.com |
Contact: Steffen Gazarek, Dr., Engineer | +49 1729135662 | steffen.gazarek@vitatron.com |
Germany | |
Klinikum Coburg | Recruiting |
Coburg, Germany, 96450 | |
Contact: V. Schibgilla, MD +49 9561220 ext 6348 v.schibgilla@t-online.de | |
Principal Investigator: V. Schibgilla, MD | |
Kardiologische Praxis | Recruiting |
Starnberg-Percha, Germany, 82319 | |
Contact: A. Frey, MD +49 8151559055 kardiologie-sta@t-online.de | |
Principal Investigator: A. Frey, MD | |
Universitätskrankenhaus Eppendorf | Recruiting |
Hamburg, Germany, 20251 | |
Contact: A. Schuchert, MD +49 40428030 ext 5765 schuchert@uke.uni-hamburg.de | |
Principal Investigator: A. Schuchert, MD | |
Kardiologische Gemeinschaftspraxis | Recruiting |
Papenburg, Germany, 26871 | |
Contact: A. Wilke, MD +49 4961992013 Praxis@Kardiologie-Papenburg.de | |
Principal Investigator: A. Wilke, MD | |
Sophien- und Hufelandklinikum GmbH | Recruiting |
Weimar, Germany, 99425 | |
Contact: E. Ebner, PD MD +49 3643571100 innere1@klinikum-weimar.de | |
Principal Investigator: E. Ebner, PD MD |
Principal Investigator: | Volker Schibgilla, MD | Unaffiliated |
Study ID Numbers: | MODEST V.2.2.1 |
Study First Received: | September 9, 2005 |
Last Updated: | October 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00161551 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Cardiac Pacing, artificial Atrial Fibrillation Heart Failure Pacemaker leads Pacing Mode |
Heart Failure Heart Diseases Heart Block Arrhythmia, Sinus |
Atrial Fibrillation Sick Sinus Syndrome Arrhythmias, Cardiac |
Disease Pathologic Processes Syndrome Cardiovascular Diseases |