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The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome

Launched by THE DANPACE INVESTIGATOR GROUP · Oct 10, 2005

Trial Information

Current as of May 12, 2025

Terminated

Keywords

ClinConnect Summary

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 ventricular (VVI) pacemaker, or a dual chamber (DDD) pacemaker. In the USA and in most European countries, DDD pacing is used in most cases. It is now known from the Danish AAI/VVI trial, that AAI pacing is superior to VVI pacing, since VVI pacing is associated with a higher mortality and a higher incidence of atrial fibrillation, thromboembolic complications and heart failure. This confirms previous...

Gender

ALL

Eligibility criteria

  • 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.

About The Danpace Investigator Group

The Danpace Investigator Group is a dedicated consortium of clinical researchers specializing in innovative pharmacological studies and trials. Committed to advancing medical knowledge and improving patient outcomes, the group focuses on cardiovascular health, particularly in the management of atrial fibrillation and related conditions. With a robust network of experienced investigators and a strong emphasis on ethical practices and regulatory compliance, the Danpace Investigator Group aims to foster collaboration and drive high-quality research that translates into effective therapeutic solutions. Their commitment to scientific excellence and patient welfare positions them as a leader in the field of clinical research.

Locations

Aarhus, , Denmark

Patients applied

0 patients applied

Trial Officials

Henning R Andersen, MD, DMSc

Principal Investigator

Skejby Sygehus, Aarhus University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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