Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein … (NCT05817318) | Clinical Trial Compass
TerminatedNot Applicable
Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation
Stopped: Study prematurely terminated by 23.09.2025 due to very slow patient recruitment.
Switzerland6 participantsStarted 2023-06-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 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 syncope in the past 3 years.
* History of orthostatic hypotension
* 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.
* 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 creatinine equation (Chronic Kidney Disease Epidemiology)
* Female of childbearing potential (age \<50 years and last menstruation within t…