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

February 20, 2009 updated by: The DANPACE Investigator Group

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1415

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8200
        • Department of Cardiology, Skejby Sygehus, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AAIR
Device: AAIR/DDDR pacemaker
Pacemaker with single lead or dual lead
Other: DDDR
Device: AAIR/DDDR pacemaker
Pacemaker with single lead or dual lead

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The DANPACE Investigator Group

Investigators

  • Principal Investigator: Henning R Andersen, MD, DMSc, Skejby Sygehus, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

October 10, 2005

First Submitted That Met QC Criteria

October 10, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

February 24, 2009

Last Update Submitted That Met QC Criteria

February 20, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25100
  • NCT00236158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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