None listed
Conditions
Brief summary
The purpose of this study is to determine whether or not the reduction of Atrial Fibrillation (AF) by the AF Suppression algorithm halts or reverses the electrical remodeling that has already begun in AF Patients
Interventions
This study aims at determining whether or not the reduction of Atrial Fibrillation (AF) by the AF suppression algorithm halts or reverses electrical remodeling that has already begun in AF patients. The algorithm provides stimulation that controls the atrial rate and rhythm minimising ectopic beats, long-short cycles and dispersion of refractoriness. It does this by monitoring the intrinsic atrial rhythm and then adapting the pacing rate slightly above the intrinsic rhythm to help ensure a high
This study aims at determining whether or not the reduction of Atrial Fibrillation (AF) by the AF suppression algorithm halts or reverses electrical remodeling that has already begun in AF patients. The algorithm provides stimulation that controls the atrial rate and rhythm minimising ectopic beats, long-short cycles and dispersion of refractoriness. It does this by monitoring the intrinsic atrial rhythm and then adapting the pacing rate slightly above the intrinsic rhythm to help ensure a high percentage of atrial pacing that is dynamically tailored to the patients rate variations. From the point of implant the device is constantly monitoring and correcting the pacing of the heart. The duration of the study is 6 months, the device will remain implanted and continue to treat the patient: Changing of the status of the AF supression algorithm being 'ON' or 'OFF' is at the discretion of the physician.
Sponsors
St. Jude Medical
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
- Patient must have standard indications for a DDD (Dual Chamber) pacemaker - Patient must have documented paroxysmal or persistent Atrial Fibrillation (AF). - Patient must be maintained on a stable antiarrhythmic drug regimen
Exclusion criteria
- Patient has chronic Atrial Fibrillation - Patient has Class 3 or 4 angina - Patient has an existing Implantable Cardioverter Defibrillator (ICD) or is being considered for an ICD implant. - Patients life expectancy is less than 6 months due to other medical conditions - Patient has a serious comorbid condition (i.e. metastaic disease, chronic renal failure etc)
Outcome results
None listed