COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034526
Recruitment Status : Recruiting
First Posted : January 13, 2014
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
Aalborg University Hospital
Herning Hospital
Regionshospitalet Viborg, Skive
Aabenraa Hospital
Sydvestjysk Hospital
Vejle Hospital
Odense University Hospital
Zealand University Hospital
Rigshospitalet, Denmark
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Hillerod Hospital, Denmark
Information provided by (Responsible Party):
Jens Cosedis Nielsen, Aarhus University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Sinus Node Disease Atrial Fibrillation Device: DDDR-60 Device: DDD-40 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2014
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to first episode of AF>6 min detected by the pacemaker [ Time Frame: Within two years ]

Secondary Outcome Measures :
  1. Time to first episode of AF>6 hours detected by the pacemaker [ Time Frame: Within two years ]
  2. Time to first episode of AF>24 hours detected by the pacemaker [ Time Frame: Within two years ]
  3. Time to direct current (DC) cardioversion or medical cardioversion for AF [ Time Frame: Within two years ]
  4. Time to stroke, transient ischemic attack (TIA), or thromboembolic event [ Time Frame: Within two years ]
  5. Time to death [ Time Frame: Within two years ]
  6. QOL [ Time Frame: After 12 months ]
    Quality of life assessment with SF-36

  7. 6MHWT [ Time Frame: After 12 months ]
    6-minute hall walk test

  8. Time to need for reprogramming of the pacing rate (cross-over) [ Time Frame: Within 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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).
  • 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02034526


Contacts
Layout table for location 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@clin.au.dk

Locations
Layout table for location information
Denmark
Department of Cardiology, Aarhus University Hospital 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@clin.au.dk   
Principal Investigator: Jens C Nielsen, prof., DMSc,         
Sponsors and Collaborators
Aarhus University Hospital
Aalborg University Hospital
Herning Hospital
Regionshospitalet Viborg, Skive
Aabenraa Hospital
Sydvestjysk Hospital
Vejle Hospital
Odense University Hospital
Zealand University Hospital
Rigshospitalet, Denmark
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Hillerod Hospital, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Jens C Nielsen, prof., DMSc, Department of Cardiology, Aarhus University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jens Cosedis Nielsen, Jens Cosedis Nielsen, professor, MD, DMSc, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02034526    
Other Study ID Numbers: M-2013-225-13
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by Jens Cosedis Nielsen, Aarhus University Hospital:
Sinus node disease
Atrial fibrillation
Pacing
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Arrhythmia, Sinus
Heart Block
Cardiac Conduction System Disease