Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation
NCT ID: NCT04182620
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2020-07-08
2025-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Catheter ablation + renal denervation
Catheter ablation + renal denervation
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
Catheter ablation only
Catheter ablation
Catheter ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vivek Reddy
OTHER
Responsible Party
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Vivek Reddy
Professor
Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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University of Arizona - Banner University Medical Center
Phoenix, Arizona, United States
Arizona Heart Institute
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Loma Linda University Medical
Loma Linda, California, United States
Pacific Heart Institute
Santa Monica, California, United States
Hartford Healthcare
Hartford, Connecticut, United States
Naples Community Hospital
Naples, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Bellin Memorial Hospital Inc.
Green Bay, Wisconsin, United States
Countries
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Other Identifiers
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IRB 19-02659
Identifier Type: OTHER
Identifier Source: secondary_id
GCO 40-5118
Identifier Type: -
Identifier Source: org_study_id
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