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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.