Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Medtronic BRC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vitatron GmbH
Information provided by:
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00161551
First received: September 9, 2005
Last updated: August 1, 2011
Last verified: October 2006
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • 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:
  • Number of patients with atrial fibrillation or heart failure > NYHA II
  • AF burden
  • Symptomatic atrial fibrillation
  • Time period to first recurrence of AF
  • Number of patients without recurrence of AF
  • Mean duration of sinus rhythm
  • Course of Wenckebach point
  • Second- and third-degree AV block
  • Reprogramming from AAI to DDD
  • Fraction of atrial versus ventricular pacing
  • Safety of treatment, complications
  • Number of cardioversions
  • Patients with persistent atrial fibrillation (AF >48h)
  • Patients with permanent atrial fibrillation (AF throughout the follow-up period)
  • Hospital admissions for cardiac reasons

Estimated Enrollment: 402
Study Start Date: November 2004
Estimated Study Completion Date: December 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161551

Contacts
Contact: Matthias Reimers, Dipl. Documentalist +49 21152930 Matthias.reimers@vitatron.com
Contact: Steffen Gazarek, Dr., Engineer +49 1729135662 steffen.gazarek@vitatron.com

Locations
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         
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         
Kardiologische Praxis Recruiting
Starnberg-Percha, Germany, 82319
Contact: A. Frey, MD    +49 8151559055    kardiologie-sta@t-online.de   
Principal Investigator: A. Frey, 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         
Sponsors and Collaborators
Medtronic BRC
Vitatron GmbH
Investigators
Principal Investigator: Volker Schibgilla, MD
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00161551     History of Changes
Other Study ID Numbers: MODEST V.2.2.1
Study First Received: September 9, 2005
Last Updated: August 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic BRC:
Cardiac Pacing, artificial
Atrial Fibrillation
Heart Failure
Pacemaker leads
Pacing Mode

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on September 14, 2014