Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation (ULTRA-HFIB)
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ClinicalTrials.gov Identifier: NCT04182620 |
Recruitment Status :
Active, not recruiting
First Posted : December 2, 2019
Last Update Posted : February 15, 2024
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Condition or disease | Intervention/treatment | Phase |
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Atrial Fibrillation | Device: renal denervation Device: Catheter ablation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Patients will be blinded until the 6 month visit, at which time they will be un-blinded prior to the follow up CT/MRI. The Clinical Events Committee and Echo Core Lab will remain blinded throughout the trial. In general, the CEC will be blinded to the treatment arms. However, once the nature of the event has been adjudicated, the blind will be broken for that individual patient as necessary to enable the CEC to determine relatedness to the study device. |
Primary Purpose: | Treatment |
Official Title: | Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study |
Actual Study Start Date : | July 8, 2020 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Catheter ablation + renal denervation
Catheter ablation + renal denervation
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Device: renal denervation
Renal denervation using the Paradise renal denervation system - a dedicated RDN catheter that delivers a circumferential ring of ablative ultrasound energy Device: Catheter ablation Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation |
Active Comparator: Catheter ablation only
Catheter ablation
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Device: Catheter ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation |
- Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds [ Time Frame: 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.
- Freedom from AT/AF/AFL recurrence [ Time Frame: 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
- Rate of procedural adverse events [ Time Frame: 30 days ]Rate of procedural adverse events
- The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire [ Time Frame: 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.
- Change in office systolic blood pressure change from baseline to 12 months [ Time Frame: 12 months ]Change in office systolic blood pressure change from baseline to 12 months
- AF burden at 6 months [ Time Frame: 6 months ]AF burden at 6 months
- AF burden at 12 months [ Time Frame: 12 months ]AF burden at 12 months
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182620
United States, Arizona | |
University of Arizona - Banner University Medical Center | |
Phoenix, Arizona, United States, 85004 | |
Arizona Heart Institute | |
Phoenix, Arizona, United States, 85016 | |
United States, Arkansas | |
Arrhythmia Research Group | |
Jonesboro, Arkansas, United States, 72401 | |
United States, California | |
Loma Linda University Medical | |
Loma Linda, California, United States, 92354 | |
Pacific Heart Institute | |
Santa Monica, California, United States, 90404 | |
United States, Connecticut | |
Hartford Healthcare | |
Hartford, Connecticut, United States, 06106 | |
United States, Florida | |
Naples Community Hospital | |
Naples, Florida, United States, 34102 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
Mount Sinai Hospital | |
New York, New York, United States, 10029 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Texas Cardiac Arrhythmia Research Foundation | |
Austin, Texas, United States, 78705 | |
United States, Wisconsin | |
Bellin Memorial Hospital Inc. | |
Green Bay, Wisconsin, United States, 54305 |
Principal Investigator: | Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai |
Responsible Party: | Vivek Reddy, Professor, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT04182620 |
Other Study ID Numbers: |
GCO 40-5118 IRB 19-02659 ( Other Identifier: Icahn School of Medicine at Mount Sinai ) |
First Posted: | December 2, 2019 Key Record Dates |
Last Update Posted: | February 15, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
renal denervation atrial fibrillation cardiology electrophysiology |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |