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

Primary Purpose

Sick Sinus Syndrome

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
AAIR/DDDR pacemaker
Sponsored by
The DANPACE Investigator Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sick Sinus Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiology, Skejby Sygehus, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

AAIR

DDDR

Arm Description

Outcomes

Primary Outcome Measures

All cause mortality after a mean follow-up of 5.5 year.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2005
Last Updated
February 20, 2009
Sponsor
The DANPACE Investigator Group
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1. Study Identification

Unique Protocol Identification Number
NCT00236158
Brief Title
The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
Official Title
The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
Not able to recruit the estimated number of patients
Study Start Date
March 1999 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The DANPACE Investigator Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 1,900 patients have been randomised. The last randomised patient has been followed for at least 1 year. The mean follow-up for the whole study population is at least 5.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AAIR
Arm Type
Other
Arm Title
DDDR
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
AAIR/DDDR pacemaker
Intervention Description
Pacemaker with single lead or dual lead
Primary Outcome Measure Information:
Title
All cause mortality after a mean follow-up of 5.5 year.
Time Frame
5,5 years
Secondary Outcome Measure Information:
Title
Cardiovascular death
Time Frame
5,5 years
Title
Chronic atrial fibrillation
Time Frame
5,5 years
Title
Paroxysmal atrial fibrillation
Time Frame
5,5 years
Title
Arterial thromboembolism
Time Frame
5,5 years
Title
Congestive heart failure
Time Frame
5,5 years
Title
Need for pacemaker re-operations
Time Frame
5,5 years
Title
Quality of life
Time Frame
5,5 years
Title
Health economics
Time Frame
5,5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning R Andersen, MD, DMSc
Organizational Affiliation
Skejby Sygehus, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Skejby Sygehus, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23449923
Citation
Kirkfeldt RE, Andersen HR, Nielsen JC; DANPACE Investigators. System upgrade and its complications in patients with a single lead atrial pacemaker: data from the DANPACE trial. Europace. 2013 Aug;15(8):1166-73. doi: 10.1093/europace/eut039. Epub 2013 Feb 28.
Results Reference
derived
PubMed Identifier
22106360
Citation
Nielsen JC, Thomsen PE, Hojberg S, Moller M, Riahi S, Dalsgaard D, Mortensen LS, Nielsen T, Asklund M, Friis EV, Christensen PD, Simonsen EH, Eriksen UH, Jensen GV, Svendsen JH, Toff WD, Healey JS, Andersen HR; DANPACE investigators. Atrial fibrillation in patients with sick sinus syndrome: the association with PQ-interval and percentage of ventricular pacing. Europace. 2012 May;14(5):682-9. doi: 10.1093/europace/eur365. Epub 2011 Nov 20.
Results Reference
derived
PubMed Identifier
21300730
Citation
Nielsen JC, Thomsen PE, Hojberg S, Moller M, Vesterlund T, Dalsgaard D, Mortensen LS, Nielsen T, Asklund M, Friis EV, Christensen PD, Simonsen EH, Eriksen UH, Jensen GV, Svendsen JH, Toff WD, Healey JS, Andersen HR; DANPACE Investigators. A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome. Eur Heart J. 2011 Mar;32(6):686-96. doi: 10.1093/eurheartj/ehr022. Epub 2011 Feb 7.
Results Reference
derived

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

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