Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sick Sinus Syndrome

Intervention / Treatment
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* Device: Vitatron T70 DR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vitatron T70 DR|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Pacing, artificial, Atrial Fibrillation, Heart Failure, Pacemaker leads, Pacing Mode