The aim of this study is to investigate whether renal denervation can reduce arrhythmia burden in patients with recurrent, paroxysmal atrial fibrillation despite durable pulmonary vein isolation.
Pulmonary vein isolation is the treatment of choice in symptomatic patients with paroxysmal atrial fibrillation. Despite durable pulmonary vein isolation, 15% of patients continue to have episodes of atrial fibrillation because of triggers of atrial fibrillation localized outside the pulmonary veins. Additional ablation of these triggers is difficult because they often cannot be localized. The autonomous nervous system does influence these triggers and modulation of the autonomous nervous system with the goal to reduce sympathetic activity may be an alternative approach to suppress these extra-pulmonary vein triggers. Renal denervation does reduce sympathetic activity and is successfully used to treat drug-resistant arterial hypertension. The combination of pulmonary vein isolation with renal denervation has already been shown to be superior to pulmonary vein isolation alone in patients with paroxysmal atrial fibrillation regarding arrhythmia-free outcome. The investigators hypothesize that renal denervation can suppress atrial fibrillation in patients with recurrent episodes of paroxysmal atrial fibrillation despite durable isolation of the pulmonary veins. The best way to assess atrial fibrillation burden is with an implantable cardiac monitor (ICM), which the investigators will use both before and after renal denervation, to gather detailed data on daily atrial fibrillation burden.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Arrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor
Universitätsspital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Change in atrial fibrillation burden
The primary endpoint is the atrial fibrillation burden in the 6 months following renal denervation compared to the 3 months before renal denervation as assessed by the ICM.
Time frame: 6 months
Freedom from atrial fibrillation recurrence
Freedom from atrial fibrillation recurrence at 12 months after renal denervation
Time frame: 12 months
Time to first atrial fibrillation recurrence after renal denervation
Time frame: 12 month
Change in mean number of days with atrial fibrillation
Mean number of days with atrial fibrillation in the 6 months following renal denervation compared to the 3 months before, as assessed by the ICM.
Time frame: 6 months
Evolution of AF burden measured as mean number of days with atrial fibrillation in the 12 months following renal denervation, as compared to before renal denervation
Evolution of AF burden measured as mean number of days with atrial fibrillation in the 12 months following renal denervation, as compared to before renal denervation
Time frame: 12 months
Evolution of AF burden measured as mean number of days with atrial fibrillation in the 3 years following renal denervation, as compared to before renal denervation
Evolution of AF burden measured as mean number of days with atrial fibrillation in the 3 years following renal denervation, as compared to before renal denervation
Time frame: 3 years
Change in arterial blood pressure after renal denervation
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Arterial blood pressure 3 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).
Time frame: 3 months
Change in arterial blood pressure after renal denervation
Arterial blood pressure 12 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).
Time frame: 12 months
Change in day heart rate following renal denervation
Day heart rate following renal denervation compared to before, as assessed by the ICM.
Time frame: 12 months
Change in patient activity
Patient activity following renal denervation compared to before, as assessed by the ICM
Time frame: 12 months
Change in heart rate variability
Heart rate variability following renal denervation compared to before, as assessed by the ICM.
Time frame: 12 months
Change in arterial blood pressure after renal denervation
Arterial blood pressure 3 months after renal denervation compared to before (office blood pressure measurements).
Time frame: 3 months
Change in arterial blood pressure after renal denervation
Arterial blood pressure 12 months after renal denervation compared to before (office blood pressure measurements).
Time frame: 12 month
Change in night heart rate following renal denervation
Night heart rate following renal denervation compared to before, as assessed by the ICM.
Time frame: 12 months