Status:
TERMINATED
The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
Lead Sponsor:
The DANPACE Investigator Group
Conditions:
Sick Sinus Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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)....
Detailed Description
Background In patients with isolated SSS, who need pacemaker treatment, any pacemaker can be used to treat the symptomatic bradycardia: a single chamber atrial (AAI) pacemaker, a single chamber ventri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1415 Patients enrolled
Trial Details
Trial ID
NCT00236158
Start Date
March 1 1999
End Date
July 1 2010
Last Update
February 24 2009
Active Locations (1)
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1
Department of Cardiology, Skejby Sygehus, Aarhus University Hospital
Aarhus, Denmark, DK-8200