Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation

Overview

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).

Full Title of Study: “Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Catheter ablation + renal denervation
    • Catheter ablation + renal denervation
  • Active Comparator: Catheter ablation only
    • Catheter ablation

Clinical Trial Outcome Measures

Primary Measures

  • Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
    • Time Frame: 12 months
    • 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.

Secondary Measures

  • Freedom from AT/AF/AFL recurrence
    • Time Frame: 12 months
    • Freedom from AT/AF/AFL recurrence through 12 months (excluding a 90-day blanking period from the initial ablation procedure) irrespective of AADs
  • Rate of procedural adverse events
    • Time Frame: 30 days
    • Rate of procedural adverse events
  • The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
    • Time Frame: 12 months
    • 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.
  • Change in office systolic blood pressure change from baseline to 12 months
    • Time Frame: 12 months
    • Change in office systolic blood pressure change from baseline to 12 months
  • AF burden at 6 months
    • Time Frame: 6 months
    • AF burden at 6 months
  • AF burden at 12 months
    • Time Frame: 12 months
    • AF burden at 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years of age;
  • Planned for 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 or;
  • Receiving ≥1 antihypertensive medication;
  • Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria

  • 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 pre-procedural CT/MRI);
  • Main renal artery diameter < 3.5 mm 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%
  • Accessory arteries with diameter ≥ 2 mm < 3.5 mm
  • 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 trial

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vivek Reddy
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Vivek Reddy, Professor – Icahn School of Medicine at Mount Sinai
  • Overall Official(s)
    • Vivek Reddy, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai
  • Overall Contact(s)
    • Sam Cammack, MA, MPH, 212-824-8931, sam.cammack@mountsinai.org

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