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

Atrial Fibrillation Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034526
• Other study ID #: M-2013-225-13
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2024
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Sick Sinus Syndrome
• Sinus Node Disease

Intervention

Device:
• DDDR-60
DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
• DDD-40
DDD, lower pacing rate 40 bpm, RR function off

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Aarhus University Hospital	Aarhus N

Sponsors (13)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aabenraa Hospital, Aalborg University Hospital, Bispebjerg Hospital, Herning Hospital, Hillerod Hospital, Denmark, Hospital of South West Jutland, Odense University Hospital, Regionshospitalet Viborg, Skive, Rigshospitalet, Denmark, University Hospital, Gentofte, Copenhagen, Vejle Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to first episode of AF>6 hours detected by the pacemaker	First episode of AF > 6 hours detected by the device	Within two years
Secondary	Time to first episode of AF>24 hours detected by the pacemaker	First episode of AF > 24 hours detected by the device	Within two years
Secondary	Time to direct current (DC) cardioversion or medical cardioversion for AF	Time to direct current (DC) cardioversion or medical cardioversion for AF	Within two years
Secondary	Time to stroke, transient ischemic attack (TIA), or thromboembolic event	Time to stroke, transient ischemic attack (TIA), or thromboembolic event	Within two years
Secondary	Time to death	Time to all cause death	Within two years
Secondary	QOL	Quality of life assessment with SF-36	After 12 months
Secondary	6MHWT	6-minute hall walk test	After 12 months
Secondary	Time to need for reprogramming of the pacing rate (cross-over)	Time to need for reprogramming of the pacing rate (cross-over)	Within 2 years

External Links

•   Publication of the main results