NCT00236158

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,415

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

11.3 years

First QC Date

October 10, 2005

Last Update Submit

February 20, 2009

Conditions

Sick Sinus Syndrome

Outcome Measures

Primary Outcomes (1)

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

    5,5 years

Secondary Outcomes (8)

  • Cardiovascular death

    5,5 years

  • Chronic atrial fibrillation

    5,5 years

  • Paroxysmal atrial fibrillation

    5,5 years

  • Arterial thromboembolism

    5,5 years

  • Congestive heart failure

    5,5 years

  • +3 more secondary outcomes

Study Arms (2)

AAIR

OTHER
Device: AAIR/DDDR pacemaker

DDDR

OTHER
Device: AAIR/DDDR pacemaker

Interventions

AAIR/DDDR pacemakerDEVICE

Pacemaker with single lead or dual lead

AAIRDDDR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Skejby Sygehus, Aarhus University Hospital

Aarhus, DK-8200, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 23449923DERIVED

  • 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.

    PMID: 22106360DERIVED

  • 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.

    PMID: 21300730DERIVED

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, SinusArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesHeart BlockCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henning R Andersen, MD, DMSc

    Skejby Sygehus, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2005

First Posted

October 12, 2005

Study Start

March 1, 1999

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations

DK(1)