Clinical trial NCT04182620: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: renal denervation
atrial fibrillation
cardiology
electrophysiology
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from AT/AF/AFL recurrence
timeFrame: 12 months
measure: Rate of procedural adverse events
timeFrame: 30 days
measure: The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
timeFrame: 12 months
measure: Change in office systolic blood pressure change from baseline to 12 months
timeFrame: 12 months
measure: AF burden at 6 months
timeFrame: 6 months
measure: AF burden at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona - Banner University Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Green Bay
country: United States
facility: Bellin Memorial Hospital Inc.
state: Wisconsin
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: