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Trials / Completed

CompletedNCT01170611

Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease

Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
400 (actual)
Sponsor
LivaNova · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.

Detailed description

In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.

Conditions

Interventions

TypeNameDescription
DEVICEPACEMAKER SYMPHONY 2550

Timeline

Start date
2004-07-01
Completion
2007-01-01
First posted
2010-07-27
Last updated
2010-07-27

Locations

52 sites across 8 countries: United States, Belgium, France, Germany, Italy, Monaco, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT01170611. Inclusion in this directory is not an endorsement.

Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease (NCT01170611) · Clinical Trials Directory