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

• ClinicalTrials.gov Identifier: NCT04182620
• Recruitment Status: Active, not recruiting
• First Posted: December 2, 2019
• Last Update Posted: February 15, 2024
• Sponsor: Vivek Reddy
• Information provided by (Responsible Party): Vivek Reddy, Icahn School of Medicine at Mount Sinai

Tracking Information

• First Submitted Date: November 27, 2019
• First Posted Date: December 2, 2019
• Last Update Posted Date: February 15, 2024
• Actual Study Start Date: July 8, 2020
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 27, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 27, 2019)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation
• Official Title: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study
• Brief Summary: 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).
• 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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Patients will be blinded until the 6 month visit, at which time they will be un-blinded prior to the follow up CT/MRI. The Clinical Events Committee and Echo Core Lab will remain blinded throughout the trial. In general, the CEC will be blinded to the treatment arms. However, once the nature of the event has been adjudicated, the blind will be broken for that individual patient as necessary to enable the CEC to determine relatedness to the study device.

Primary Purpose: Treatment

• Condition: Atrial Fibrillation

Intervention

• 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

Study Arms

• Experimental: Catheter ablation + renal denervation
  Catheter ablation + renal denervation
  Interventions:

  • Device: renal denervation
  • Device: Catheter ablation
• Active Comparator: Catheter ablation only
  Catheter ablation
  Intervention: Device: Catheter ablation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 23, 2022): 160
• Original Estimated Enrollment (submitted: November 27, 2019): 130
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Czechia, Germany

Administrative Information

• NCT Number: NCT04182620
• Other Study ID Numbers: GCO 40-5118; IRB 19-02659 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Vivek Reddy, Icahn School of Medicine at Mount Sinai
• Original Responsible Party: Same as current
• Current Study Sponsor: Vivek Reddy
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Icahn School of Medicine at Mount Sinai
• Verification Date: February 2024