ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
Sick Sinus Syndrome Device: AAIR/DDDR pacemaker Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
Study Start Date : March 1999
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
AAIR Device: AAIR/DDDR pacemaker
Pacemaker with single lead or dual lead
DDDR Device: AAIR/DDDR pacemaker
Pacemaker with single lead or dual lead



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

Secondary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 5,5 years ]
  2. Chronic atrial fibrillation [ Time Frame: 5,5 years ]
  3. Paroxysmal atrial fibrillation [ Time Frame: 5,5 years ]
  4. Arterial thromboembolism [ Time Frame: 5,5 years ]
  5. Congestive heart failure [ Time Frame: 5,5 years ]
  6. Need for pacemaker re-operations [ Time Frame: 5,5 years ]
  7. Quality of life [ Time Frame: 5,5 years ]
  8. Health economics [ Time Frame: 5,5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236158


Locations
Denmark
Department of Cardiology, Skejby Sygehus, Aarhus University Hospital
Aarhus, Denmark, DK-8200
Sponsors and Collaborators
The DANPACE Investigator Group
Investigators
Principal Investigator: Henning R Andersen, MD, DMSc Skejby Sygehus, Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henning Rud Andersen, Aarhus University Hospital Skejby, Departm. of Cardiology
ClinicalTrials.gov Identifier: NCT00236158     History of Changes
Other Study ID Numbers: 25100
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Syndrome
Sick Sinus Syndrome
Disease
Pathologic Processes
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block