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Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161551
Recruitment Status : Unknown
Verified October 2006 by Medtronic BRC.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : August 2, 2011
Vitatron GmbH
Information provided by:
Medtronic BRC

Brief Summary:
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 or disease Intervention/treatment Phase
Sick Sinus Syndrome Device: Vitatron T70 DR Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Prospective Multicenter Study to Determine the Incidence of Atrial Fibrillation and Heart Failure in Correlation to Stimulation Modes of Pacemakers
Study Start Date : November 2004
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Primary objective is to assess how the pacing mode affects the incidence of atrial fibrillation (AF) in patients with sick sinus syndrome. Since there are no data on the safety of AAI pacing in patients with Wenckebach points < 120 bpm and accor

Secondary Outcome Measures :
  1. Number of patients with atrial fibrillation or heart failure > NYHA II
  2. AF burden
  3. Symptomatic atrial fibrillation
  4. Time period to first recurrence of AF
  5. Number of patients without recurrence of AF
  6. Mean duration of sinus rhythm
  7. Course of Wenckebach point
  8. Second- and third-degree AV block
  9. Reprogramming from AAI to DDD
  10. Fraction of atrial versus ventricular pacing
  11. Safety of treatment, complications
  12. Number of cardioversions
  13. Patients with persistent atrial fibrillation (AF >48h)
  14. Patients with permanent atrial fibrillation (AF throughout the follow-up period)
  15. Hospital admissions for cardiac reasons

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic sinus bradycardia, Sinusarrest
  • Symptomatic SA block
  • Bradycardia-Tachycardia-Syndrome
  • Binodal diseases

Exclusion Criteria:

  • 1st degree AV Block
  • 2nd degree AV block
  • 3rd degree AV block
  • Total right bundle branch block
  • Indication for biventricular stimulation
  • Inter atrial conduction delays (P-wave > 150MS)
  • Permanent or therapy refractory Atrial Fibrillation
  • Heart Failure acc. NYHA III or IV
  • Myocardial Infarction less than 6 months before pacemaker implant
  • Hypertrophic obstructive cardiomyopathy
  • Symptomatic hypo- or hyperthyreosis
  • Cardiogenic shock
  • Pregnancy
  • Lactation period
  • Unstable angina pectoris
  • Poorly controlled Diabetes mellitus
  • Neuromuscular diseases
  • Patients under 18 years of age
  • Patients involved in other studies
  • Reduced expectancy of life due to other diseases
  • Patients who cannot attend follow-up visits regularly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00161551

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Contact: Matthias Reimers, Dipl. Documentalist +49 21152930
Contact: Steffen Gazarek, Dr., Engineer +49 1729135662

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Klinikum Coburg Recruiting
Coburg, Germany, 96450
Contact: V. Schibgilla, MD    +49 9561220 ext 6348   
Principal Investigator: V. Schibgilla, MD         
Universitätskrankenhaus Eppendorf Recruiting
Hamburg, Germany, 20251
Contact: A. Schuchert, MD    +49 40428030 ext 5765   
Principal Investigator: A. Schuchert, MD         
Kardiologische Gemeinschaftspraxis Recruiting
Papenburg, Germany, 26871
Contact: A. Wilke, MD    +49 4961992013   
Principal Investigator: A. Wilke, MD         
Kardiologische Praxis Recruiting
Starnberg-Percha, Germany, 82319
Contact: A. Frey, MD    +49 8151559055   
Principal Investigator: A. Frey, MD         
Sophien- und Hufelandklinikum GmbH Recruiting
Weimar, Germany, 99425
Contact: E. Ebner, PD MD    +49 3643571100   
Principal Investigator: E. Ebner, PD MD         
Sponsors and Collaborators
Medtronic BRC
Vitatron GmbH
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Principal Investigator: Volker Schibgilla, MD

Layout table for additonal information Identifier: NCT00161551    
Other Study ID Numbers: MODEST V.2.2.1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: October 2006
Keywords provided by Medtronic BRC:
Cardiac Pacing, artificial
Atrial Fibrillation
Heart Failure
Pacemaker leads
Pacing Mode
Additional relevant MeSH terms:
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Sick Sinus Syndrome
Pathologic Processes
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Cardiac Conduction System Disease