ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
NCT ID: NCT05988411
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2023-12-07
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Catheter ablation + renal denervation
Catheter ablation + renal denervation
Renal Denervation
Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (RDN) catheter that delivers a circumferential ring of ablative ultrasound energy
Catheter Ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.
Catheter ablation only
Catheter ablation
Catheter Ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.
Interventions
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Renal Denervation
Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (RDN) catheter that delivers a circumferential ring of ablative ultrasound energy
Catheter Ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Vivek Reddy
OTHER
Responsible Party
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Vivek Reddy
Professor of Medicine , Director, Cardiac Electrophysiology
Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Arrhythmia Research Group
Jonesboro, Arkansas, United States
UCSF
San Francisco, California, United States
Los Robles Medical Center
Thousand Oaks, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
Trident Medical Center
Charleston, South Carolina, United States
Christus
Tyler, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRANY 23-02-344
Identifier Type: -
Identifier Source: org_study_id
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