Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome. (DANPACEII)
Primary Purpose
Sinus Node Disease, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DDDR-60
DDD-40
Sponsored by
About this trial
This is an interventional treatment trial for Sinus Node Disease focused on measuring Sinus node disease, Atrial fibrillation, Pacing
Eligibility 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.
Sites / Locations
- Department of Cardiology, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
DDDR-60
DDD-40
Arm Description
DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
DDD, lower pacing rate 40 bpm, RR function off
Outcomes
Primary Outcome Measures
Time to first episode of AF>6 min detected by the pacemaker
First episode of AF > 6 min detected by the device
Secondary Outcome Measures
Time to first episode of AF>6 hours detected by the pacemaker
First episode of AF > 6 hours detected by the device
Time to first episode of AF>24 hours detected by the pacemaker
First episode of AF > 24 hours detected by the device
Time to direct current (DC) cardioversion or medical cardioversion for AF
Time to direct current (DC) cardioversion or medical cardioversion for AF
Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Time to death
Time to all cause death
QOL
Quality of life assessment with SF-36
6MHWT
6-minute hall walk test
Time to need for reprogramming of the pacing rate (cross-over)
Time to need for reprogramming of the pacing rate (cross-over)
Full Information
NCT ID
NCT02034526
First Posted
January 10, 2014
Last Updated
June 19, 2023
Sponsor
Aarhus University Hospital
Collaborators
Aalborg University Hospital, Herning Hospital, Regionshospitalet Viborg, Skive, Aabenraa Hospital, Hospital of South West Jutland, Vejle Hospital, Odense University Hospital, Zealand University Hospital, Rigshospitalet, Denmark, Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Hillerod Hospital, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02034526
Brief Title
Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.
Acronym
DANPACEII
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 Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
Aalborg University Hospital, Herning Hospital, Regionshospitalet Viborg, Skive, Aabenraa Hospital, Hospital of South West Jutland, Vejle Hospital, Odense University Hospital, Zealand University Hospital, Rigshospitalet, Denmark, Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Hillerod Hospital, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Disease, Atrial Fibrillation
Keywords
Sinus node disease, Atrial fibrillation, Pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DDDR-60
Arm Type
Placebo Comparator
Arm Description
DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
Arm Title
DDD-40
Arm Type
Experimental
Arm Description
DDD, lower pacing rate 40 bpm, RR function off
Intervention Type
Device
Intervention Name(s)
DDDR-60
Intervention Description
DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
Intervention Type
Device
Intervention Name(s)
DDD-40
Intervention Description
DDD, lower pacing rate 40 bpm, RR function off
Primary Outcome Measure Information:
Title
Time to first episode of AF>6 min detected by the pacemaker
Description
First episode of AF > 6 min detected by the device
Time Frame
Within two years
Secondary Outcome Measure Information:
Title
Time to first episode of AF>6 hours detected by the pacemaker
Description
First episode of AF > 6 hours detected by the device
Time Frame
Within two years
Title
Time to first episode of AF>24 hours detected by the pacemaker
Description
First episode of AF > 24 hours detected by the device
Time Frame
Within two years
Title
Time to direct current (DC) cardioversion or medical cardioversion for AF
Description
Time to direct current (DC) cardioversion or medical cardioversion for AF
Time Frame
Within two years
Title
Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Description
Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Time Frame
Within two years
Title
Time to death
Description
Time to all cause death
Time Frame
Within two years
Title
QOL
Description
Quality of life assessment with SF-36
Time Frame
After 12 months
Title
6MHWT
Description
6-minute hall walk test
Time Frame
After 12 months
Title
Time to need for reprogramming of the pacing rate (cross-over)
Description
Time to need for reprogramming of the pacing rate (cross-over)
Time Frame
Within 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens C Nielsen, prof., DMSc,
Organizational Affiliation
Department of Cardiology, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.
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