Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

Phase 4

• Conditions: Sick Sinus Syndrome

• Registration Number: NCT00161551
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Status Verified: 2006-10
• Study Completion: 2010-12
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 402

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Universitätskrankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

Klinikum Coburg; 🇩🇪 Coburg, Germany

Kardiologische Gemeinschaftspraxis; 🇩🇪 Papenburg, Germany

Kardiologische Praxis; 🇩🇪 Starnberg-Percha, Germany

Sophien- und Hufelandklinikum GmbH; 🇩🇪 Weimar, Germany