Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
NCT ID: NCT01170611
Last Updated: 2010-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2004-07-31
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD
PACEMAKER SYMPHONY 2550
Interventions
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PACEMAKER SYMPHONY 2550
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Universitätklinik. Lübeck - Germany
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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
CHU de Limoges Hôpital Dupuytren
Limoges, , France
Clinique Clairval
Marseille, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
Polyclinique de Gentilly
Nancy, , France
Nouvelles Cliniques Nantaises
Nantes, , France
Hôpital Pasteur
Nice, , France
Hôpital Pitié-Salpêtrière
Paris, , France
InParys CLINIQUE BIZET
Paris, , France
CHU Haut l'Evêque
Pessac, , France
CHU Pontchaillou
Rennes, , France
CHU - Hôpital Charles Nicolle
Rouen, , France
Centre Cardiologique du Nord
Saint-Denis, , France
Centre Hospitalier Rangueil
Toulouse, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Hufeland Krankenhaus GmbH
Bad Langensalza, , Germany
Charite Campus Virchow
Berlin, , Germany
Kliniken der Stadt Köln
Cologne, , Germany
Universitätklinikum Leipzig
Leipzig, , Germany
Universitätklinik. Lübeck
Lübeck, , Germany
Klinikum Lüdenscheid
Lüdenscheid, , Germany
Johannes Gutenberg-Universität - Mainz Klinikum
Mainz, , Germany
Klinikum Memmingen
Memmingen, , Germany
Ospedale San Tommaso dei Battuti
Portogruaro, VE, Italy
CH Princesse Grace
Monaco, , Monaco
Complejo Hospitalario Universitario de Vigo (CHUVI)
Pontevedra, , Spain
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom
St Peters Hospital
Chertsey, Surrey, United Kingdom
Countries
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Other Identifiers
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IPRE03
Identifier Type: -
Identifier Source: secondary_id
PREFACE-IPRE03
Identifier Type: -
Identifier Source: org_study_id
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