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CompletedNCT01170611Updated Jul 27, 2010

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

A Phase 4 interventional study of PACEMAKER SYMPHONY 2550 in Sinus Node Dysfunction and Brady Tachy Syndrome, sponsored by LivaNova. Completed at 52 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-27.

Sponsored by LivaNova · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sinus Node Dysfunction
  • Brady Tachy Syndrome

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03

In context

Sick Sinus Syndrome

89 studies on the registry are indexed under Sick Sinus Syndrome; 17 are open to participants now.

This study's enrollment of 400 is above the median of 129 across 60 interventional studies indexed under Sick Sinus Syndrome.

Browse Sick Sinus Syndrome studies →

Lead sponsor

LivaNova is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD

    Device: PACEMAKER SYMPHONY 2550

Interventions

  • DevicePACEMAKER SYMPHONY 2550
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What researchers measure

Primary outcomes

  1. Atrial arrhythmia burden

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Study locations

52 sites
  • 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
    Bruxelles, 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 Cedex 5, 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
    Vandoeuvre Les Nancy, 54500, France
  • Hufeland Krankenhaus GmbH
    Bad Langensalza, 99947, Germany
  • Charite Campus Virchow
    Berlin, 13353, Germany
  • Kliniken der Stadt Köln
    Köln, 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01170611
Lead sponsor
LivaNova
First posted
Jul 27, 2010
Start date
Jul 2004
Completion
Jan 2007
Last update
Jul 27, 2010
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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