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Kidney ultrasound may help keep heart rhythm steady after second AFib procedure

NCT ID NCT05988411

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests whether adding a kidney nerve treatment (renal denervation) to a repeat catheter ablation for atrial fibrillation (AFib) can lower the chance of AFib coming back. About 250 people with high blood pressure and AFib who need a second ablation will be randomly assigned to get ablation alone or ablation plus the kidney treatment. The main goal is to see if the combination keeps the heart in normal rhythm longer without needing extra heart-rhythm drugs.

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 using the Paradise ultrasound catheter
What this could lead to
If successful, this could offer a new way to lower the chance of atrial fibrillation coming back after a repeat ablation procedure, especially for people with high blood pressure.
What could go wrong
This is a small pilot study, so results are preliminary. The added procedure carries risks like any catheter-based intervention, and it may not reduce AFib recurrence more than ablation alone.

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

143 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Dec 2027

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: * Age ≥ 18; * Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.) * History of hypertension and either: * Documented history of SBP≥160 or DBP≥100, or; * Receiving ≥1 antihypertensive medication; * Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements Exclusion Criteria: * Long-standing persistent AF (\>12 months); \>3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium. * Individual with valvular AF or AF due to a reversible cause * Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device. * NYHA class IV congestive heart failure; * Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography); * Main renal artery diameter \<3mm or \>8.0 mm * Main renal treatable artery length \< 20 mm (length may include proximal branches) * Presence of renal artery stenosis of any origin ≥30% * Calcification in renal arteries * Prior renal denervation procedure * Presence of abnormal kidney tumors * Renal artery aneurysm * Pre-existing renal stent or history of renal artery angioplasty * Pre-existing aortic stent or history of aortic aneurysm * Fibromuscular disease of the renal arteries * Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter * Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation; * Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation) * Individual with known allergy to contrast medium not amendable to treatment. * Life expectancy \<1 year for any medical condition * Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit. * Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis. * Female participants who are pregnant or nursing. * Individual has known secondary hypertension. * Individual has a single functioning kidney (either congenitally or iatrogenically). * Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. * Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this protocol.

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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

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Christus

    Tyler, Texas, 75702, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Los Robles Medical Center

    Thousand Oaks, California, 91360, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Trident Medical Center

    Charleston, South Carolina, 29406, United States

  • UCSF

    San Francisco, California, 94143, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

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