Trial record 2 of 49 for:    "sick sinus syndrome" OR "sinus node disease" OR "sinus node dysfunction"

Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome. (DANPACEII)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Jens Cosedis Nielsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT02034526
First received: January 10, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Sinus Node Disease
Atrial Fibrillation
Device: DDDR-60
Device: DDD-40

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome and Dual Chamber Pacemaker.

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Time to first episode of AF>6 min detected by the pacemaker [ Time Frame: Within two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first episode of AF>6 hours detected by the pacemaker [ Time Frame: Within two years ] [ Designated as safety issue: No ]
  • Time to first episode of AF>24 hours detected by the pacemaker [ Time Frame: Within two years ] [ Designated as safety issue: No ]
  • Time to DC cardioversion or medical cardioversion for AF [ Time Frame: Within two years ] [ Designated as safety issue: No ]
  • Time to stroke, TCI, or thromboembolic event [ Time Frame: Within two years ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: Within two years ] [ Designated as safety issue: No ]
  • QOL [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
    Quality of life assessment with SF-36

  • 6MHWT [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
    6-minute hall walk test

  • Time to need for reprogramming of the pacing rate (cross-over) [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: DDDR-60
DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
Device: DDDR-60
DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
Experimental: DDD-40
DDD, lower pacing rate 40 bpm, RR function off
Device: DDD-40
DDD, lower pacing rate 40 bpm, RR function off

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sick sinus syndrome 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.

Exclusion Criteria:

  • 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).
  • Persisting second or third degree AV block.
  • Life expectancy <2 years.
  • Participation in another interventional research study.
  • Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
  • Pregnancy.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034526

Contacts
Contact: Jens C Nielsen, prof., DMSc. + 45 78 45 00 00 jenniels@rm.dk
Contact: Mads B Kronborg, MD, PhD + 45 78 45 00 00 mads.brix.kronborg@ki.au.dk

Locations
Denmark
Department of Cardiology, Aarhus University Hospital Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Jens C Nielsen, prof., DMSc.    +45 78 45 00 00    jenniels@rm.dk   
Contact: Mads B Kronborg, MD, PhD.    +45 78 45 00 00    mads.brix.kronborg@ki.au.dk   
Principal Investigator: Jens C Nielsen, prof., DMSc,         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Jens C Nielsen, prof., DMSc, Department of Cardiology, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Jens Cosedis Nielsen, Jens Cosedis Nielsen, professor, MD, DMSc, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02034526     History of Changes
Other Study ID Numbers: M-2013-225-13
Study First Received: January 10, 2014
Last Updated: January 10, 2014
Health Authority: Denmark: National Board of Health

Keywords provided by Aarhus University Hospital:
Sinus node disease
Atrial fibrillation
Pacing

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

ClinicalTrials.gov processed this record on September 30, 2014