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Kidney nerve treatment studied for stubborn heart rhythm problem

NCT ID NCT05817318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

6 people

The number who actually took part.

Started

Jun 2023

Finished

Sep 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Universitätsspital Basel

    Basel, 4031, Switzerland

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