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
  Purpose

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 Intervention Phase
Sinus Node Dysfunction
Brady Tachy Syndrome
Device: PACEMAKER SYMPHONY 2550
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Atrial arrhythmia burden [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: July 2004
Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD Device: PACEMAKER SYMPHONY 2550

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170611

  Show 52 Study Locations
Sponsors and Collaborators
Sorin Group
  More Information

No publications provided

Responsible Party: WIEGAND, Universitätklinik. Lübeck - Germany
ClinicalTrials.gov Identifier: NCT01170611     History of Changes
Other Study ID Numbers: PREFACE-IPRE03, IPRE03
Study First Received: July 22, 2010
Last Updated: July 26, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014