Status:
COMPLETED
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
Lead Sponsor:
LivaNova
Conditions:
Sinus Node Dysfunction
Brady Tachy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 eff...
Eligibility Criteria
Inclusion
- A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
- A PR interval \<250ms AND
- Documented atrial arrhythmia in the past year
- Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
- Patients must have less than two known cardioversions within the last year
- Patient has signed a consent form after having received the appropriate information
Exclusion
- Need a replacement pacemaker device
- Have an unknown PR interval
- Known AV block ≥ 250 ms PR interval
- Minor and/or pregnant woman
- Patients enrolled in other clinical trials
- Patients with sustained ventricular arrhythmia
- Patients with severe coronary artery disease (at the discretion of the investigator)
- Patients with advanced cardiomyopathy (at the discretion of the investigator)
- Patients who have sustained a myocardial infarction or undergone cardiac surgery within the past 30 days
- Patients with unstable angina pectoris
- Patients whose life expectancy is less than 1 year
- Patients who are unlikely to return for required follow-up visits
- Patients who present with permanent atrial arrhythmia or those who usually require cardioversion to terminate such arrhythmia and/or
- Patients whose physician plans to add or change medical treatment because of AA episodes during the follow-up period.
- Patient unable to understand the purpose of the study or refusing to cooperate
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01170611
Start Date
July 1 2004
End Date
January 1 2007
Last Update
July 27 2010
Active Locations (52)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Banner Baywood Heart Hospital
Mesa, Arizona, United States, 85206
3
Brentwood Biomedical Research Institute
Los Angeles, California, United States, 90073
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121