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

July 26, 2010 updated by: LivaNova

Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD
Device: PACEMAKER SYMPHONY 2550

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Atrial arrhythmia burden

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREFACE-IPRE03
  • IPRE03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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