Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161551
Status:
UNKNOWN
Last Update Posted:
2011-08-02
First Post:
2005-09-09
Brief Title:
Mode Evaluation in Sick Sinus Syndrome Trial MODEST
Sponsor:
Medtronic BRC
Organization:
Medtronic BRC
Study Overview
Official Title:
A Randomized Prospective Multicenter Study to Determine the Incidence of Atrial Fibrillation and Heart Failure in Correlation to Stimulation Modes of Pacemakers
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None