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

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ClinicalTrials.gov Identifier: NCT01170611
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : July 27, 2010
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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.

Condition or disease Intervention/treatment Phase
Sinus Node Dysfunction Brady Tachy Syndrome Device: PACEMAKER SYMPHONY 2550 Phase 4

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  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease
Study Start Date : July 2004
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment

Primary Outcome Measures :
  1. Atrial arrhythmia burden

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170611

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Sponsors and Collaborators

Responsible Party: WIEGAND, Universitätklinik. Lübeck - Germany
ClinicalTrials.gov Identifier: NCT01170611     History of Changes
Other Study ID Numbers: PREFACE-IPRE03
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010

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