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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 22, 2010
Last Updated Date	July 26, 2010
Start Date ^ICMJE	July 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: July 26, 2010)	Atrial arrhythmia burden [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01170611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
Official Title ^ICMJE	Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease
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.
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 ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Sinus Node Dysfunction Brady Tachy Syndrome
Intervention ^ICMJE	Device: PACEMAKER SYMPHONY 2550
Study Arm (s)	Experimental: AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD Intervention: Device: PACEMAKER SYMPHONY 2550
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date	January 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, France, Germany, Italy, Monaco, Spain, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01170611
Other Study ID Numbers ^ICMJE	PREFACE-IPRE03, IPRE03
Has Data Monitoring Committee	Not Provided
Responsible Party	WIEGAND, Universitätklinik. Lübeck - Germany
Study Sponsor ^ICMJE	Sorin Group
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sorin Group
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top