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

This study has been completed.
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01170611
First received: July 22, 2010
Last updated: July 26, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Sinus Node Dysfunction
Brady Tachy Syndrome
Device: PACEMAKER SYMPHONY 2550
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Atrial arrhythmia burden [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: July 2004
Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD Device: PACEMAKER SYMPHONY 2550

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170611

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Baywood Heart Hospital
Mesa, Arizona, United States, 85206
United States, California
Brentwood Biomedical Research Institute
Los Angeles, California, United States, 90073
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Jersey
Passaic Beth Israel Regional Medical Center
Passaic, New Jersey, United States, 07055
United States, North Carolina
NorthEast Medical Center
Concord, North Carolina, United States, 28025
United States, Oklahoma
Hillcrest Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Lancaster Regional Medical Center
Lancaster, Pennsylvania, United States, 17603
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Belgium
OLV Aalst
Aalst, Belgium, 9300
Cliniques Sud Luxembourg
Arlon, Belgium, 6700
Clinique Saint-Jean
Bruxelles, Belgium, 1000
Algemeen Ziekenhuis Sint-Dimpna
Geel, Belgium, 2440
Centre Hospitalier Hutois
Huy, Belgium, 4500
CHU Tivoli
La Louvière, Belgium, 7100
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium, 2610
UCL Mont-Godinne
Yvoir, Belgium, 5530
France
CHG d'Albi
Albi, France, 81013
CHRU du Morvan Hôpital la Cavale Blanche
Brest, France, 29069
Hospice St-Jacques-Hôpital G.Montpied
Clermond-Ferrand, France, 63003
Hôpital Henri Mondor
Créteil, France, 94010
C.H.I. du Val d'Ariège
Foix, France, 09017
CHRU de Grenoble Hôpital Michallon
Grenoble, France, 38043
Polyclinique du Bois
Lille, France, 59003
CHU de Limoges Hôpital Dupuytren
Limoges, France, 87042
Clinique Clairval
Marseille, France, 13009
Hôpital Arnaud de Villeneuve
Montpellier Cedex 5, France, 34295
Polyclinique de Gentilly
Nancy, France, 54100
Nouvelles Cliniques Nantaises
Nantes, France, 44277
Hôpital Pasteur
Nice, France, 6000
Hôpital Pitié-Salpêtrière
Paris, France, 75013
InParys CLINIQUE BIZET
Paris, France, 75016
CHU Haut l'Evêque
Pessac, France, 33604
CHU Pontchaillou
Rennes, France, 35033
CHU - Hôpital Charles Nicolle
Rouen, France, 76031
Centre Cardiologique du Nord
Saint Denis, France, 93200
Centre Hospitalier Rangueil
Toulouse, France, 31403
CHU Brabois
Vandoeuvre Les Nancy, France, 54500
Germany
Hufeland Krankenhaus GmbH
Bad Langensalza, Germany, 99947
Charite Campus Virchow
Berlin, Germany, 13353
Kliniken der Stadt Köln
Köln, Germany, D-51067
Universitätklinikum Leipzig
Leipzig, Germany, D-04103
Universitätklinik. Lübeck
Lübeck, Germany, 23538
Klinikum Lüdenscheid
Lüdenscheid, Germany, D-58515
Johannes Gutenberg-Universität - Mainz Klinikum
Mainz, Germany, D-55101
Klinikum Memmingen
Memmingen, Germany, 87700
Italy
Ospedale San Tommaso dei Battuti
Portogruaro, VE, Italy, 30026
Monaco
CH Princesse Grace
Monaco, Monaco, 98012
Spain
Complejo Hospitalario Universitario de Vigo (CHUVI)
Pontevedra, Spain, 36204
United Kingdom
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom, BN21 2UD
St Peters Hospital
Chertsey, Surrey, United Kingdom, KT16 0PZ
Sponsors and Collaborators
Sorin Group
  More Information

No publications provided

Responsible Party: WIEGAND, Universitätklinik. Lübeck - Germany
ClinicalTrials.gov Identifier: NCT01170611     History of Changes
Other Study ID Numbers: PREFACE-IPRE03, IPRE03
Study First Received: July 22, 2010
Last Updated: July 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Block
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014