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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    130
  • sponsor
    Vivek Reddy
Updated on 9 March 2021
hypertension
fibrillation
antihypertensive drugs
catheter ablation
antihypertensive agents
pulmonary vein isolation

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.

Details
Condition Arrhythmia, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment catheter ablation, Renal denervation
Clinical Study IdentifierNCT04182620
SponsorVivek Reddy
Last Modified on9 March 2021

Eligibility

Yes No Not Sure

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 SBP160 or DBP100 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
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