Kidney nerve treatment studied for stubborn heart rhythm problem
NCT ID NCT05817318
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a procedure called renal denervation could help people with recurrent atrial fibrillation (an irregular heartbeat) that keeps coming back even after standard treatment. The procedure uses energy to calm certain nerves near the kidneys. Only 6 people took part before the study was stopped early, so we cannot draw firm conclusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- renal denervation (a medical device procedure that uses energy to calm nerves near the kidneys)
- What this could lead to
- If it worked, this could offer a new option for people whose atrial fibrillation keeps coming back after standard ablation.
- What could go wrong
- The trial was terminated early with only 6 participants, so results are very limited. It is unclear if the procedure is effective or safe for this use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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6 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 the last 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 or if 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Inselspital Bern
Bern, 3010, Switzerland
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Universitätsspital Basel
Basel, 4031, Switzerland
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Other studies related to the condition(s) this trial covers.
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