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Nerve-Zapping kidney procedure may boost heart rhythm treatment

NCT ID NCT05116384

Disease control Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether adding a kidney nerve-zapping procedure (renal artery denervation) to the standard heart ablation procedure can better control persistent atrial fibrillation (AF). About 50 adults with persistent AF and controlled or no high blood pressure will be randomly assigned to receive either standard ablation alone or ablation plus the kidney procedure. The main goal is to see if the combination reduces the total time spent in AF over the long term, measured by a heart monitor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
renal artery denervation (a procedure using radiofrequency energy to disrupt nerves in the kidney arteries) plus catheter ablation (using cryo energy to isolate pulmonary veins)
What this could lead to
If successful, this combination procedure could reduce the amount of time people with persistent atrial fibrillation spend in an irregular heart rhythm, potentially improving long-term outcomes.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to everyone. The added procedure carries risks like blood vessel damage, and it is unclear if the benefit outweighs those risks.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

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: 1. Age \> 18 years 2. Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation \> 7 days and up to 1 year) 3. No prior history of HTN or HTN controlled on medical therapy (defined as SBP \<140 mm Hg and DBP \<85 mm Hg) 4. Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram 5. Willingness to undergo ILR placement 6. Willingness to comply with post-procedural follow-up requirements and to sign informed consent. Exclusion Criteria: 1. Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation) 2. Prior left atrial ablation for an atrial arrhythmia 3. NYHA class IV congestive heart failure or LVEF \< 25% 4. Paroxysmal AF, or longstanding persistent AF (duration \> 1 year) 5. Coronary revascularization or valve surgery within 3 months 6. Prior valve surgery using a mechanical prosthesis 7. Renal artery anatomy that is ineligible for treatment including: 1. Predicted inability to access renal vasculature 2. Main renal arteries \< 4 mm in diameter or \< 20 mm in length. 3. Hemodynamically or anatomically significant renal artery abnormality or stenosis 4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment 5. Multiple main renal arteries to either kidney 8. An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation 9. Life expectancy \<1 year for any medical condition

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Rochester

    RECRUITING

    Short Hills, New Jersey, 07078, United States

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