Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation (ULTRA-HFIB)

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

The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: renal denervation; Device: Catheter ablation

Detailed Description

The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of AF recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention). This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 11 clinical sites in the United States and Europe.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Heart Institute
    • Phoenix, Arizona, United States, 85004
      • University of Arizona - Banner University Medical Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical
    • Santa Monica, California, United States, 90404
      • Pacific Heart Institute
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Healthcare
  • Florida
    • Naples, Florida, United States, 34102
      • Naples Community Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54305
      • Bellin Memorial Hospital Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• Planned for a first-ever AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as involving pulmonary vein isolation, 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)

• History of hypertension and either:

  • Documented history of SBP ≥ 160 or DBP ≥ 100 (Stage III), or
  • Receiving ≥ 1 antihypertensive medication
• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria:

(if any of the following are YES, subject is not eligible)

• Long-standing persistent AF (> 12 months)
• Individual with valvular AF or AF due to a reversible cause
• Prior left atrial catheter or surgical ablation for an atrial arrhythmia (before this index procedure)
• Prior left atrial surgery (such as mitral valve surgery or surgical ASD repair)
• 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 intra-procedural renal angiography). This includes:

  • Main renal artery diameter < 3.0 mm or > 8.0 mm
  • Main renal artery length < 20 mm
  • Presence of renal artery stenosis of any origin ≥ 30%
  • Accessory arteries with diameter ≥ 2 mm and < 3.0 mm
  • Calcification in renal arteries at locations where energy is to be delivered
  • 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
• Inability to undergo AF catheter ablation (e.g., presence of left atrial thrombus, contraindication to all anticoagulation)
• Individual with known allergy to contrast medium not amenable to treatment
• Life expectancy of < 1 year for any medical condition
• Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of screening 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 trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter ablation + renal denervation	Device: renal denervation; Renal denervation using the Paradise renal denervation system - a dedicated RDN catheter that delivers a circumferential ring of ablative ultrasound energy; Device: Catheter ablation; Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation
Active Comparator: Catheter ablation only; Catheter ablation	Device: Catheter ablation; Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds	Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds off Class I and III AADs (after the 90-day blanking period), defined by absence of any electrocardiographically documented AT/AF.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from AT/AF/AFL recurrence	Freedom from AT/AF/AFL recurrence through 12 months (excluding a 90-day blanking period from the initial ablation procedure) irrespective of AADs	12 months
Rate of procedural adverse events	Rate of procedural adverse events	30 days
The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire	Quality of life instrument (AFEQT) is a 20-item disease-specific scale developed to capture subjective ratings of AF disease and treatment burden. Full range score from 0-100, with higher score indicating higher level of quality of life.	12 months
Change in office systolic blood pressure change from baseline to 12 months	Change in office systolic blood pressure change from baseline to 12 months	12 months
AF burden at 6 months	AF burden at 6 months	6 months
AF burden at 12 months	AF burden at 12 months	12 months

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Investigators: Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): February 26, 2025

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: atrial fibrillation; renal denervation; electrophysiology; cardiology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: GCO 40-5118; IRB 19-02659 (Other Identifier: Icahn School of Medicine at Mount Sinai)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes