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Paroxysmal Atrial FibrillationNCT05988411

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

A study testing Renal Denervation and Catheter Ablation in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Vivek Reddy at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Renal Denervation and Catheter Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
8 sitesUnited States
Study dates
7 Dec 2023to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

  • Mount Sinai Hospital

    New York, New York, 10029

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • UCSF

    San Francisco, California, 94143

  • Los Robles Medical Center

    Thousand Oaks, California, 91360

  • Christus

    Tyler, Texas, 75702

Other trials in United States

About this study

Official title: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: A Pilot Study

This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Read the detailed description

This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 20 clinical sites in the United States. Once the clinical sites are up and running (expected to take 6 months), accrual is expected to take an additional 9 months, and all patients will be followed for 12 months post randomization. Patients, the Clinical Events Committee and the ECG core lab will be blinded during the trial. Patients will be unblinded at the 12-month visit.

Being tested
Renal Denervation, Catheter Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal DenervationDevice

    Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (RDN) catheter that delivers a circumferential ring of ablative ultrasound energy

  • Catheter AblationDevice

    Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.

Study groups in NCT05988411
Study groupRoleWhat they receive
Catheter ablation + renal denervationExperimentalCatheter ablation + renal denervation
Receives: Device: Renal Denervation; Device: Catheter Ablation
Catheter ablation onlyActive comparatorCatheter ablation
Receives: Device: Catheter Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from atrial arrhythmias with no AADs

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

    Measured: after 90 days

Secondary outcomes (5)

  1. Freedom from atrial arrhythmias (AT/AF/AFL) with AADs

    Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs

    Measured: at 12 months

  2. Procedure-related adverse events

    Number of procedure-related adverse events

    Measured: at 12 months

  3. Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)

    Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.

    Measured: at 12 months

  4. Blood pressure

    Blood pressure - Systolic and Diastolic

    Measured: at 12 months

  5. Number of AF episodes

    AF burden assessed by the amount of AF episodes detected during Event Monitoring

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start7 Dec 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial.
Masking
Single blind
Who is masked
Participant
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05988411
Sponsor's protocol ID
BRANY 23-02-344
Status last verified
Jul 2026
First submitted
4 Aug 2023
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Renal Denervation and Catheter Ablation in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Vivek Reddy at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from atrial arrhythmias with no AADs (time frame: after 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05988411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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