Sick Sinus Syndrome Clinical Trial
Official title:
The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
Verified date | February 2009 |
Source | The DANPACE Investigator Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
Hypothesis Treatment with rate adaptive single chamber atrial pacing (AAIR) reduces the risk
of death compared with rate adaptive dual chamber pacing (DDDR) in patients with sick sinus
syndrome (SSS).
Primary purpose The primary purpose of this randomised trial is to compare AAIR and DDDR
pacing in patients with SSS and normal atrioventricular (AV) conduction with respect to the
primary end point overall mortality.
Status | Terminated |
Enrollment | 1415 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: General: A. Undergoing primary pacemaker implantation B. Able to appear for outpatient follow-up C. Age > 18 years Symptoms: D. Syncope or E. Dizzy spells or F. Congestive heart failure Electrocardiographic: G. Sinus bradycardia <40/minute for at least 1 minute in a conscious awake state or H. Sinus arrest/sinoatrial block >2 seconds or I. Bradycardia/tachycardia with sinus-pauses >2 seconds Exclusion Criteria: Clinical: A. Malignant disease. B. Severe psychogenic disease including severe decrepitude and dementia. C. Impending larger operation expected to influence the major end point. D. Cardiac disorder expected to need cardiac surgery during the follow-up period. E. Need for other device implantation: ICD (implantable cardioverter defibrillator) or implantable DC converter (for atrial fibrillation). F. Carotid sinus syndrome (positive carotid sinus massage with pauses >3 seconds). Electrocardiographic: G. Atrioventricular block. H. Bundle-branch block (complete RBBB, LBBB, bifascicular bundle-branch block or non-specific intraventricular block with QRS >0.12 seconds). I. Chronic atrial fibrillation. J. Atrial fibrillation/atrial flutter with QRS pauses >3 seconds during atrial fibrillation. K. Atrial fibrillation/atrial flutter with QRS frequency <40/minute for 1 minute. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Cardiology, Skejby Sygehus, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
The DANPACE Investigator Group |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All cause mortality after a mean follow-up of 5.5 year. | 5,5 years | Yes | |
Secondary | Cardiovascular death | 5,5 years | Yes | |
Secondary | Chronic atrial fibrillation | 5,5 years | No | |
Secondary | Paroxysmal atrial fibrillation | 5,5 years | No | |
Secondary | Arterial thromboembolism | 5,5 years | No | |
Secondary | Congestive heart failure | 5,5 years | No | |
Secondary | Need for pacemaker re-operations | 5,5 years | No | |
Secondary | Quality of life | 5,5 years | No | |
Secondary | Health economics | 5,5 years | No |
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