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ULTRA-HFIB-Redo Study for Atrial Fibrillation

This study is for people with atrial fibrillation (AFib), an irregular heartbeat, who are planning to have a second (redo) catheter ablation procedure. It aims to see if adding renal denervation (using the Paradise renal denervation system, which uses ultrasound to treat nerves near the kidneys) to the standard catheter ablation procedure can better prevent AFib from returning. You could be eligible if you are 18 or older and are scheduled for a redo AFib ablation. The study will compare patients who receive only catheter ablation to those who receive both catheter ablation and renal denervation. Success will be measured by how many patients remain free from AFib without needing antiarrhythmic drugs after 90 days. The current recruitment status is unclear, and the study plans to enroll 250 participants.

Study design
This is a controlled, single-blind study where participants are randomly assigned to one of two groups (2:1 ratio for intervention vs. control). It plans to enroll 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
All patients will be followed for 12 months after they are assigned to a study group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05988411

ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Vivek Reddy
~143 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Renal DenervationCatheter Ablation

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from atrial arrhythmias with no AADs
Measured over after 90 days

Conditions

Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation

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Atrial Fibrillation

NCT05988411

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arrhythmia Research Group

    Jonesboro, Arkansasno site contact published

  • Christus

    Tyler, Texasno site contact published

  • Henry Ford Health System

    Detroit, Michiganno site contact published

  • Los Robles Medical Center

    Thousand Oaks, Californiano site contact published

  • Mount Sinai Hospital

    New York, New Yorkno site contact published

  • Trident Medical Center

    Charleston, South Carolinano site contact published

  • UCSF

    San Francisco, Californiano site contact published

  • Virginia Commonwealth University

    Richmond, Virginiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Vivek Reddy, MD · PRINCIPAL_INVESTIGATOR · MOUNT SINAI HOSPITAL

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Freedom from atrial arrhythmias with no AADsafter 90 days

    Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).