NCT02034526

Brief Summary

Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF. The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

8.9 years

First QC Date

January 10, 2014

Last Update Submit

February 6, 2024

Conditions

Sinus Node DiseaseAtrial Fibrillation

Keywords

Sinus node diseaseAtrial fibrillationPacing

Outcome Measures

Primary Outcomes (1)

  • Time to first episode of AF>6 min detected by the pacemaker

    First episode of AF \> 6 min detected by the device

    Within two years

Secondary Outcomes (8)

  • Time to first episode of AF>6 hours detected by the pacemaker

    Within two years

  • Time to first episode of AF>24 hours detected by the pacemaker

    Within two years

  • Time to direct current (DC) cardioversion or medical cardioversion for AF

    Within two years

  • Time to stroke, transient ischemic attack (TIA), or thromboembolic event

    Within two years

  • Time to death

    Within two years

  • +3 more secondary outcomes

Study Arms (2)

DDDR-60

PLACEBO COMPARATOR

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

Device: DDDR-60

DDD-40

EXPERIMENTAL

DDD, lower pacing rate 40 bpm, RR function off

Device: DDD-40

Interventions

DDDR-60DEVICE

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

DDDR-60
DDD-40DEVICE

DDD, lower pacing rate 40 bpm, RR function off

DDD-40

Eligibility Criteria

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

You may qualify if:

  • Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (\>2 sec) or bradycardia with or without paroxysmal AF.
  • Age ≥18 years.
  • Patient informed consent.

You may not qualify if:

  • Permanent or persisting (\>7 days) AF prior to implantation.
  • Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of \>40 bpm is indicated (verified with long term ECG monitoring).
  • Life expectancy \<2 years.
  • Participation in another interventional research study.
  • Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

  • Kronborg MB, Frausing MHJP, Malczynski J, Riahi S, Haarbo J, Holm KF, Larroude CE, Albertsen AE, Svendstrup L, Hintze U, Pedersen OD, Davidsen U, Fischer T, Johansen JB, Kristensen J, Gerdes C, Nielsen JC; DANPACE II Investigators. Atrial pacing minimization in sinus node dysfunction and risk of incident atrial fibrillation: a randomized trial. Eur Heart J. 2023 Oct 21;44(40):4246-4255. doi: 10.1093/eurheartj/ehad564.

    PMID: 37638973DERIVED

MeSH Terms

Conditions

Sick Sinus SyndromeAtrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jens C Nielsen, prof., DMSc,

    Department of Cardiology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jens Cosedis Nielsen, professor, MD, DMSc, PhD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 13, 2014

Study Start

May 1, 2014

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

DK(1)