Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
2 other identifiers
interventional
400
8 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2004
Typical duration for phase_4
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 27, 2010
CompletedJuly 27, 2010
July 1, 2010
July 22, 2010
July 26, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Atrial arrhythmia burden
Study Arms (1)
AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (52)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Banner Baywood Heart Hospital
Mesa, Arizona, 85206, United States
Brentwood Biomedical Research Institute
Los Angeles, California, 90073, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Passaic Beth Israel Regional Medical Center
Passaic, New Jersey, 07055, United States
NorthEast Medical Center
Concord, North Carolina, 28025, United States
Hillcrest Medical Center
Tulsa, Oklahoma, 74104, United States
Lancaster Regional Medical Center
Lancaster, Pennsylvania, 17603, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
OLV Aalst
Aalst, 9300, Belgium
Cliniques Sud Luxembourg
Arlon, 6700, Belgium
Clinique Saint-Jean
Brussels, 1000, Belgium
Algemeen Ziekenhuis Sint-Dimpna
Geel, 2440, Belgium
Centre Hospitalier Hutois
Huy, 4500, Belgium
CHU Tivoli
La Louvière, 7100, Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, 2610, Belgium
UCL Mont-Godinne
Yvoir, 5530, Belgium
CHG d'Albi
Albi, 81013, France
CHRU du Morvan Hôpital la Cavale Blanche
Brest, 29069, France
Hospice St-Jacques-Hôpital G.Montpied
Clermond-Ferrand, 63003, France
Hôpital Henri Mondor
Créteil, 94010, France
C.H.I. du Val d'Ariège
Foix, 09017, France
CHRU de Grenoble Hôpital Michallon
Grenoble, 38043, France
Polyclinique du Bois
Lille, 59003, France
CHU de Limoges Hôpital Dupuytren
Limoges, 87042, France
Clinique Clairval
Marseille, 13009, France
Hôpital Arnaud de Villeneuve
Montpellier, 34295, France
Polyclinique de Gentilly
Nancy, 54100, France
Nouvelles Cliniques Nantaises
Nantes, 44277, France
Hôpital Pasteur
Nice, 6000, France
Hôpital Pitié-Salpêtrière
Paris, 75013, France
InParys CLINIQUE BIZET
Paris, 75016, France
CHU Haut l'Evêque
Pessac, 33604, France
CHU Pontchaillou
Rennes, 35033, France
CHU - Hôpital Charles Nicolle
Rouen, 76031, France
Centre Cardiologique du Nord
Saint-Denis, 93200, France
Centre Hospitalier Rangueil
Toulouse, 31403, France
CHU Brabois
Vandœuvre-lès-Nancy, 54500, France
Hufeland Krankenhaus GmbH
Bad Langensalza, 99947, Germany
Charite Campus Virchow
Berlin, 13353, Germany
Kliniken der Stadt Köln
Cologne, D-51067, Germany
Universitätklinikum Leipzig
Leipzig, D-04103, Germany
Universitätklinik. Lübeck
Lübeck, 23538, Germany
Klinikum Lüdenscheid
Lüdenscheid, D-58515, Germany
Johannes Gutenberg-Universität - Mainz Klinikum
Mainz, D-55101, Germany
Klinikum Memmingen
Memmingen, 87700, Germany
Ospedale San Tommaso dei Battuti
Portogruaro, VE, 30026, Italy
CH Princesse Grace
Monaco, 98012, Monaco
Complejo Hospitalario Universitario de Vigo (CHUVI)
Pontevedra, 36204, Spain
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD, United Kingdom
St Peters Hospital
Chertsey, Surrey, KT16 0PZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 27, 2010
Study Start
July 1, 2004
Study Completion
January 1, 2007
Last Updated
July 27, 2010
Record last verified: 2010-07