Thinking of joining a study?

Register your interest

Become a volunteer?

NCT02034526 | COMPLETED | Sinus Node Disease

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

Aarhus University Hospital

Information provided by (Responsible Party):

Jens Cosedis Nielsen

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

Sinus Node Disease

Atrial Fibrillation

Intervention/treatment

DDDR-60

DDD-40

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 540 participants
Masking : NONE
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.
Actual Study Start Date : 2014-05
Estimated Primary Completion Date : 2023-03-31
Estimated Study Completion Date : 2023-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.

Location Details

NCT02034526

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Denmark,

Department of Cardiology, Aarhus University Hospital

Aarhus N., Denmark, 8200