Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

Status Recruiting

Clinical Trial 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).

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00161551
Study type	Interventional
Source	Medtronic BRC
Contact	Matthias Reimers, Dipl. Documentalist
Phone	+49 21152930
Email	Matthias.reimers@vitatron.com
Status	Recruiting
Phase	Phase 4
Start date	November 2004
Completion date	December 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00286858` - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Active, not recruiting	`NCT00228241` - Left Ventricular Function and Remodelling During Permanent Pacing	N/A
Completed	`NCT00180557` - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads	Phase 4
Not yet recruiting	`NCT04149886` - Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome	N/A
Completed	`NCT01609738` - Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum	Phase 1/Phase 2
Completed	`NCT00785564` - Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)
Recruiting	`NCT00224341` - Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation	Phase 4
Recruiting	`NCT05575557` - Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment	N/A
Recruiting	`NCT05186220` - Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction	N/A
Completed	`NCT03843242` - Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker	N/A
Terminated	`NCT00475124` - Virtual Clinic Pacemaker Follow-up	Phase 4
Recruiting	`NCT06288633` - Cardioneuroablation for Bradyarrhythmia	N/A
Terminated	`NCT00236158` - The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome	Phase 2/Phase 3
Completed	`NCT00000561` - Mode Selection Trial in Sinus Node Dysfunction (MOST)	Phase 3
Completed	`NCT02154750` - AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals	N/A
Completed	`NCT02198781` - Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
Recruiting	`NCT01477138` - RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome	N/A
Terminated	`NCT01074749` - Optimal Sensing in Atrial Tachyarrhythmia's Study	N/A
Completed	`NCT00627328` - The Atrial High Rate Episodes in Pacemaker Patients	N/A
Completed	`NCT00161538` - Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.