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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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).

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.


Detailed 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 findings in observational studies. Therefore, VVI pacing should no longer be used in patients with SSS.

The main argument for using DDD pacing is the concern, that the patients will develop symptomatic atrioventricular (AV) block. In the Danish AAI/VVI trial, the risk of AV block was approximately 0.6% per year, which is equivalent to the risk found in a larger meta analysis. This is only a little higher that the risk of atrioventricular block in the age-matched non-paced population. Implantation of a DDD pacemaker in all patients will effectively prevent development of symptomatic bradycardia in the minority of patients who develops AV block. However, the most important disadvantage during DDD pacing is the stimulation (pacing) of the ventricles by the pacemaker a large part of the time, also in patients without AV block. Pacing the right ventricle causes an asynchronous electrical activation and mechanical contraction of the ventricles as compared with the normal physiological contraction.

At present time, a randomised comparison of AAI and DDD pacing in patients with SSS has never been conducted, and to our knowledge, such a trial is not planned anywhere else.

Since several of the pat
Sponsor: The DANPACE Investigator Group

Current Primary Outcome: All cause mortality after a mean follow-up of 5.5 year. [ Time Frame: 5,5 years ]

Original Primary Outcome: All cause mortality after a mean follow-up of 5.5 year.

Current Secondary Outcome:

  • Cardiovascular death [ Time Frame: 5,5 years ]
  • Chronic atrial fibrillation [ Time Frame: 5,5 years ]
  • Paroxysmal atrial fibrillation [ Time Frame: 5,5 years ]
  • Arterial thromboembolism [ Time Frame: 5,5 years ]
  • Congestive heart failure [ Time Frame: 5,5 years ]
  • Need for pacemaker re-operations [ Time Frame: 5,5 years ]
  • Quality of life [ Time Frame: 5,5 years ]
  • Health economics [ Time Frame: 5,5 years ]


Original Secondary Outcome:

  • Cardiovascular death
  • Chronic atrial fibrillation
  • Paroxysmal atrial fibrillation
  • Arterial thromboembolism
  • Congestive heart failure
  • Need for pacemaker re-operations
  • Quality of life
  • Health economics


Information By: The DANPACE Investigator Group

Dates:
Date Received: October 10, 2005
Date Started: March 1999
Date Completion: July 2010
Last Updated: February 20, 2009
Last Verified: February 2009