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

NCT05988411 | Recruiting DMC FDA Device

• 1 other identifier: BRANY 23-02-344
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 8

Brief 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 procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Conditions

Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (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).

  after 90 days

Secondary Outcomes (5)

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

  at 12 months

• Procedure-related adverse events

  at 12 months

• Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)

  at 12 months

• Blood pressure

  at 12 months

• Number of AF episodes

  at 12 months

Study Arms (2)

Catheter ablation + renal denervation

EXPERIMENTAL

Catheter ablation + renal denervation

Device: Renal Denervation; Device: Catheter Ablation

Catheter ablation only

ACTIVE COMPARATOR

Catheter ablation

Device: Catheter Ablation

Interventions

Catheter Ablation DEVICE

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

Catheter ablation + renal denervation; Catheter ablation only

Renal Denervation DEVICE

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 + renal denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivek Reddy: lead

Study Sites (8)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

RECRUITING

UCSF

San Francisco, California, 94143, United States

RECRUITING

Los Robles Medical Center

Thousand Oaks, California, 91360, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Trident Medical Center

Charleston, South Carolina, 29406, United States

RECRUITING

Christus

Tyler, Texas, 75702, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Vivek Reddy, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Lam, MS

CONTACT

(212) 824-8929; jeff.lam@mountsinai.org

Betsy Ellsworth, MSN ANP

CONTACT

(212) 824-8902; betsy.ellsworth@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine , Director, Cardiac Electrophysiology

Model Details: Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: December 7, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)