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

Completed · Phase 4

Conditions studied: Sinus Node Dysfunction, Brady Tachy Syndrome

In brief

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.

Key facts

Study ID

NCT01170611

Run by

LivaNova

People needed

400

Starts

2004-07-01

Expected to finish

2007-01-01

Last updated by the study team

2010-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Baywood Heart Hospital — Mesa, Arizona, United States
• Brentwood Biomedical Research Institute — Los Angeles, California, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Passaic Beth Israel Regional Medical Center — Passaic, New Jersey, United States
• NorthEast Medical Center — Concord, North Carolina, United States
• Hillcrest Medical Center — Tulsa, Oklahoma, United States
• Lancaster Regional Medical Center — Lancaster, Pennsylvania, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• OLV Aalst — Aalst, Belgium
• Cliniques Sud Luxembourg — Arlon, Belgium
• Clinique Saint-Jean — Brussels, Belgium
• Algemeen Ziekenhuis Sint-Dimpna — Geel, Belgium
• Centre Hospitalier Hutois — Huy, Belgium
• CHU Tivoli — La Louvière, Belgium
• Algemeen Ziekenhuis Sint-Augustinus — Wilrijk, Belgium
• UCL Mont-Godinne — Yvoir, Belgium
• CHG d'Albi — Albi, France
• CHRU du Morvan Hôpital la Cavale Blanche — Brest, France
• Hospice St-Jacques-Hôpital G.Montpied — Clermond-Ferrand, France
• Hôpital Henri Mondor — Créteil, France
• C.H.I. du Val d'Ariège — Foix, France
• CHRU de Grenoble Hôpital Michallon — Grenoble, France
• Polyclinique du Bois — Lille, France
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.