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

Trial details

Who runs it

Insel Gruppe AG, University Hospital Bern

Trial code

NCT05817318

Record updated

1 May 2026

Original description

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.Read full original descriptionShow less

Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation (REDE-AF): a National, Multi-centre, Prospective, Single-arm, Pre-to-post Treatment, Medical-device Study

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.

Inclusion: 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 fibrillation ablation 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 or antihypertensive drug therapy.

Exclusion: Treatment with amiodaron within the last 3 months; Mandatory treatment with class I or III antiarrhythmic drugs; Prior renal denervation; Renal artery stent or prior renal angioplasty; History of reflex syncope, syncope due to orthostatic hypotension or unclear syncope in the past 3 years; History of orthostatic hypotension; Polycystic kidney disease, unilateral kidney, or history of renal transplant; Diabetes mellitus type I; Left ventricular ejection fraction <40%; Estimated glomerular filtration rate (eGFR) < 50mL/min, using the CKD-EPI creatinine equation (Chronic Kidney Disease Epidemiology); Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy; Persistent or permanent atrial fibrillation post pulmonary vein isolation; Severe aortic or mitral valve stenosis; Abnormal blood pressure fall during active standing, defined as a progressive and sustained fall in systolic blood pressure from baseline value ≥20 mmHg or diastolic blood pressure ≥10mmHg, or a decrease in systolic blood pressure to <90 mmHg; Life expectancy <1 year; Enrolment in interventional studies if the other study does not allow enrolment or if primary endpoint might be affected by study participation; 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.

ClinicalTrials.gov NCT05817318