Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

August 1, 2011 updated by: Medtronic BRC

A Randomized, Prospective Multicenter Study to Determine the Incidence of Atrial Fibrillation and Heart Failure in Correlation to Stimulation Modes of Pacemakers

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).

Study Overview

Status

Unknown

Conditions

Sick Sinus Syndrome

Intervention / Treatment

Device: Vitatron T70 DR

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.

Study Type

Interventional

Enrollment (Anticipated)

402

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Coburg, Germany, 96450
    - Recruiting
    - Klinikum Coburg
    - Contact:
      
      V. Schibgilla, MD
      
      Phone Number: 6348 +49 9561220
      
      Email: v.schibgilla@t-online.de
    - Principal Investigator:
      
      V. Schibgilla, MD
  - Hamburg, Germany, 20251
    - Recruiting
    - Universitätskrankenhaus Eppendorf
    - Contact:
      
      A. Schuchert, MD
      
      Phone Number: 5765 +49 40428030
      
      Email: schuchert@uke.uni-hamburg.de
    - Principal Investigator:
      
      A. Schuchert, MD
  - Papenburg, Germany, 26871
    - Recruiting
    - Kardiologische Gemeinschaftspraxis
    - Contact:
      
      A. Wilke, MD
      
      Phone Number: +49 4961992013
      
      Email: Praxis@Kardiologie-Papenburg.de
    - Principal Investigator:
      
      A. Wilke, MD
  - Starnberg-Percha, Germany, 82319
    - Recruiting
    - Kardiologische Praxis
    - Contact:
      
      A. Frey, MD
      
      Phone Number: +49 8151559055
      
      Email: kardiologie-sta@t-online.de
    - Principal Investigator:
      
      A. Frey, MD
  - Weimar, Germany, 99425
    - Recruiting
    - Sophien- und Hufelandklinikum GmbH
    - Contact:
      
      E. Ebner, PD MD
      
      Phone Number: +49 3643571100
      
      Email: innere1@klinikum-weimar.de
    - Principal Investigator:
      
      E. Ebner, PD MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic BRC

Collaborators

Vitatron GmbH

Investigators

Principal Investigator: Volker Schibgilla, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

December 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2011

Last Update Submitted That Met QC Criteria

August 1, 2011

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MODEST V.2.2.1

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