Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation

Inclusion Criteria:

• Informed Consent signed by the subject

• ≥ 18 years of age

• Recurrent, paroxysmal atrial fibrillation post repeat (≥2) pulmonary vein isolation

• Documentation of atrial fibrillation ≥3 months after the last atrial fibrillationablation procedure by a 12-lead ECG or on a rhythm strip of ≥30 seconds duration

• Either an office systolic blood pressure ≥130 mmHg at the screening visit orantihypertensive drug therapy

Exclusion Criteria:

• Persistent or permanent atrial fibrillation post pulmonary vein isolation

• Left ventricular ejection fraction <40%

• Severe aortic or mitral valve stenosis

• Treatment with amiodaron within the last 3 months

• Mandatory treatment with class I or III antiarrhythmic drugs

• History of reflex syncope, syncope due to orthostatic hypotension or unclear syncopein the past 3 years.

• History of orthostatic hypotension

• Abnormal blood pressure fall during active standing, defined as a progressive andsustained fall in systolic blood pressure from baseline value ≥20 mmHg or diastolicblood pressure ≥10mmHg, or a decrease in systolic blood pressure to <90 mmHg.

• Prior renal denervation

• Renal artery stent or prior renal angioplasty

• Polycystic kidney disease, unilateral kidney, or history of renal transplant

• Estimated glomerular filtration rate (eGFR) < 50mL/min, using the CKD-EPI creatinineequation (Chronic Kidney Disease Epidemiology)

• Female of childbearing potential (age <50 years and last menstruation within thelast 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.

• Life expectancy <1 year

• Enrolment in interventional studies if the other study does not allow enrolment orif primary endpoint might be affected by study participation.

• Diabetes mellitus type I

• Aortic grafts

The following exclusion criteria will apply after the run-in phase of up to 3 months duration, prospectively in patients which receive a new ICM and retrospectively in patients which already have an ICM implanted:

• Episodes of atrial fibrillation on <6 days in the 3 months run-in phase.