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

July 22, 2010
July 26, 2010
July 2004
Not Provided
Atrial arrhythmia burden [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01170611 on ClinicalTrials.gov Archive Site
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Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sinus Node Dysfunction
  • Brady Tachy Syndrome
Device: PACEMAKER SYMPHONY 2550
Experimental: AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD
Intervention: Device: PACEMAKER SYMPHONY 2550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Germany,   Italy,   Monaco,   Spain,   United Kingdom
 
NCT01170611
PREFACE-IPRE03, IPRE03
Not Provided
WIEGAND, Universitätklinik. Lübeck - Germany
Sorin Group
Not Provided
Not Provided
Sorin Group
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP