Kidney ultrasound may help keep heart rhythm steady after second AFib procedure
NCT ID NCT05988411
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.
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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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143 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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: * 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
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Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
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Christus
Tyler, Texas, 75702, United States
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Los Robles Medical Center
Thousand Oaks, California, 91360, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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Trident Medical Center
Charleston, South Carolina, 29406, United States
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UCSF
San Francisco, California, 94143, United States
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Virginia Commonwealth University
Richmond, Virginia, 23298, United States
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