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

Phase 4

Completed

• Conditions: Sinus Node Dysfunction; Brady Tachy Syndrome
• Interventions: Device: PACEMAKER SYMPHONY 2550

• Registration Number: NCT01170611
• Lead Sponsor: LivaNova

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 effectiveness.

Study Timeline

• Study Start: 2004-07
• Study Completion: 2007-01
• Status Verified: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-26
• Last Update Submitted: 2010-07-26
• Study First Posted: 2010-07-27
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD	PACEMAKER SYMPHONY 2550	-

Primary Outcome Measures

Name	Time	Method
Atrial arrhythmia burden

Trial Locations

Locations (52)

Eastbourne District General Hospital; 🇬🇧 Eastbourne, East Sussex, United Kingdom

OLV Aalst; 🇧🇪 Aalst, Belgium

Algemeen Ziekenhuis Sint-Dimpna; 🇧🇪 Geel, Belgium

Algemeen Ziekenhuis Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

Cliniques Sud Luxembourg; 🇧🇪 Arlon, Belgium

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

CHU Tivoli; 🇧🇪 La Louvière, Belgium

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

CH Princesse Grace; 🇲🇨 Monaco, Monaco

InParys CLINIQUE BIZET; 🇫🇷 Paris, France

St Peters Hospital; 🇬🇧 Chertsey, Surrey, United Kingdom

CHG d'Albi; 🇫🇷 Albi, France

CHRU de Grenoble Hôpital Michallon; 🇫🇷 Grenoble, France

Hôpital Pasteur; 🇫🇷 Nice, France

Ospedale San Tommaso dei Battuti; 🇮🇹 Portogruaro, VE, Italy

Brentwood Biomedical Research Institute; 🇺🇸 Los Angeles, California, United States

Drexel University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Hospice St-Jacques-Hôpital G.Montpied; 🇫🇷 Clermond-Ferrand, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

C.H.I. du Val d'Ariège; 🇫🇷 Foix, France

NorthEast Medical Center; 🇺🇸 Concord, North Carolina, United States

CHU de Limoges Hôpital Dupuytren; 🇫🇷 Limoges, France

Universitätklinik. Lübeck; 🇩🇪 Lübeck, Germany

Clinique Clairval; 🇫🇷 Marseille, France

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

Lancaster Regional Medical Center; 🇺🇸 Lancaster, Pennsylvania, United States

Hillcrest Medical Center; 🇺🇸 Tulsa, Oklahoma, United States

Charite Campus Virchow; 🇩🇪 Berlin, Germany

Klinikum Lüdenscheid; 🇩🇪 Lüdenscheid, Germany

Clinique Saint-Jean; 🇧🇪 Bruxelles, Belgium

Centre Hospitalier Hutois; 🇧🇪 Huy, Belgium

Passaic Beth Israel Regional Medical Center; 🇺🇸 Passaic, New Jersey, United States

UCL Mont-Godinne; 🇧🇪 Yvoir, Belgium

CHRU du Morvan Hôpital la Cavale Blanche; 🇫🇷 Brest, France

Polyclinique de Gentilly; 🇫🇷 Nancy, France

CHU Haut l'Evêque; 🇫🇷 Pessac, France

CHU Pontchaillou; 🇫🇷 Rennes, France

CHU - Hôpital Charles Nicolle; 🇫🇷 Rouen, France

CHU Brabois; 🇫🇷 Vandoeuvre Les Nancy, France

Centre Hospitalier Rangueil; 🇫🇷 Toulouse, France

Kliniken der Stadt Köln; 🇩🇪 Köln, Germany

Complejo Hospitalario Universitario de Vigo (CHUVI); 🇪🇸 Pontevedra, Spain

Polyclinique du Bois; 🇫🇷 Lille, France

Hufeland Krankenhaus GmbH; 🇩🇪 Bad Langensalza, Germany

Johannes Gutenberg-Universität - Mainz Klinikum; 🇩🇪 Mainz, Germany

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner Baywood Heart Hospital; 🇺🇸 Mesa, Arizona, United States

Centre Cardiologique du Nord; 🇫🇷 Saint Denis, France

Universitätklinikum Leipzig; 🇩🇪 Leipzig, Germany

Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier Cedex 5, France

Klinikum Memmingen; 🇩🇪 Memmingen, Germany