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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: renal denervation; Device: Catheter ablation

• Registration Number: NCT04182620
• Lead Sponsor: Vivek Reddy

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 Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-02
• Study Start: 2020-07-08
• Primary Completion: 2025-02-26
• Study Completion: 2025-02-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter ablation + renal denervation	renal denervation	Catheter ablation + renal denervation
Catheter ablation only	Catheter ablation	Catheter ablation
Catheter ablation + renal denervation	Catheter ablation	Catheter ablation + renal denervation

Primary Outcome Measures

Name	Time	Method
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds	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 Outcome Measures

Name	Time	Method
Change in office systolic blood pressure change from baseline to 12 months	12 months	Change in office systolic blood pressure change from baseline to 12 months
AF burden at 6 months	6 months	AF burden at 6 months
AF burden at 12 months	12 months	AF burden at 12 months
Freedom from AT/AF/AFL recurrence	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
The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire	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.
Rate of procedural adverse events	30 days	Rate of procedural adverse events

Trial Locations

Locations (13)

Loma Linda University Medical; 🇺🇸 Loma Linda, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Arizona - Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Arrhythmia Research Group; 🇺🇸 Jonesboro, Arkansas, United States

Hartford Healthcare; 🇺🇸 Hartford, Connecticut, United States

Bellin Memorial Hospital Inc.; 🇺🇸 Green Bay, Wisconsin, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

Naples Community Hospital; 🇺🇸 Naples, Florida, United States

Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

Pacific Heart Institute; 🇺🇸 Santa Monica, California, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States