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

Atrial Fibrillation Clinical Trial

— ULTRA-HFIB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04182620
• Other study ID #: GCO 40-5118
• Secondary ID: IRB 19-02659
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Catheter ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Henry Ford Hospital	Detroit	Michigan
United States	Bellin Memorial Hospital Inc.	Green Bay	Wisconsin
United States	Hartford Healthcare	Hartford	Connecticut
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Loma Linda University Medical	Loma Linda	California
United States	Naples Community Hospital	Naples	Florida
United States	Mount Sinai Hospital	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Heart Institute	Phoenix	Arizona
United States	University of Arizona - Banner University Medical Center	Phoenix	Arizona
United States	Pacific Heart Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Vivek Reddy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of procedural adverse events	Rate of procedural adverse events	30 days
Secondary	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
Secondary	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
Secondary	AF burden at 6 months	AF burden at 6 months	6 months
Secondary	AF burden at 12 months	AF burden at 12 months	12 months