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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hopital 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
        • Hôpital Pitié-Salpêtrière
      • Paris, France, 75016
        • InParys CLINIQUE BIZET
      • Pessac, France, 33604
        • CHU Haut l'Evêque
      • Rennes, France, 35033
        • CHU Pontchaillou
      • Rouen, France, 76031
        • CHU - Hopital 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 Koln
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD
Device: PACEMAKER SYMPHONY 2550

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Atrial arrhythmia burden

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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