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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00236158
Recruitment Status : Terminated (Not able to recruit the estimated number of patients)
First Posted : October 12, 2005
Last Update Posted : February 24, 2009
Sponsor:
Information provided by:
The DANPACE Investigator Group

Tracking Information
First Submitted Date  ICMJE October 10, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date February 24, 2009
Study Start Date  ICMJE March 1999
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
All cause mortality after a mean follow-up of 5.5 year. [ Time Frame: 5,5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2005)
All cause mortality after a mean follow-up of 5.5 year.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
  • 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 Measures  ICMJE
 (submitted: October 10, 2005)
  • Cardiovascular death
  • Chronic atrial fibrillation
  • Paroxysmal atrial fibrillation
  • Arterial thromboembolism
  • Congestive heart failure
  • Need for pacemaker re-operations
  • Quality of life
  • Health economics
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
Official Title  ICMJE 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 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 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 patients with SSS suffer from chronotropic incompetence, pacemakers with rate adaptive function are chosen for all patients included in the present trial.

All patients, that fulfils the inclusion criteria and none of the exclusion criteria and who give written informed consent, are included into the study. For all other patients undergoing primary pacemaker implantation in the study period, an exclusion data sheet is filled in stating the reason for exclusion. A total of 1,900 patients are included into the study.

Prior to the pacemaker implantation patients are randomised by lot (envelope) to either AAIR or DDDR pacing. The randomisation is performed after written informed consent has been obtained from the patient. Randomisation will ensure that all centres will randomise an equal number of patients into each treatment group.

Patients randomised to AAIR pacing will have a bipolar lead implanted in their right atrium connected to a single chamber pacemaker with rate adaptive function. Patients randomised to DDDR pacing will have two leads (one bipolar lead in their right atrium and a uni- or bipolar lead in their right ventricle) connected to a DDDR pacemaker.

Out of hospital follow-up The patients must attend for out of hospital follow-up after 3 months and 12 months and then once every year.

Criteria for closing the study

The DANPACE study is stopped and results are analysed when all of the following three criteria are fulfilled:

  1. 1,900 patients have been randomised.
  2. The last randomised patient has been followed for at least 1 year.
  3. The mean follow-up for the whole study population is at least 5.5 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sick Sinus Syndrome
Intervention  ICMJE Device: AAIR/DDDR pacemaker
Pacemaker with single lead or dual lead
Study Arms  ICMJE
  • AAIR
    Intervention: Device: AAIR/DDDR pacemaker
  • DDDR
    Intervention: Device: AAIR/DDDR pacemaker
Publications *

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 20, 2009)
1415
Original Enrollment  ICMJE
 (submitted: October 10, 2005)
1900
Estimated Study Completion Date  ICMJE July 2010
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00236158
Other Study ID Numbers  ICMJE 25100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henning Rud Andersen, Aarhus University Hospital Skejby, Departm. of Cardiology
Study Sponsor  ICMJE The DANPACE Investigator Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henning R Andersen, MD, DMSc Skejby Sygehus, Aarhus University Hospital
PRS Account The DANPACE Investigator Group
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP