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Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation (ULTRA-HFIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182620
Recruitment Status : Not yet recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: renal denervation Device: Catheter ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Catheter ablation + renal denervation
Catheter ablation + renal denervation
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
Device: Catheter ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Rate of procedural adverse events [ Time Frame: 30 days ]
    Rate of procedural adverse events

  3. 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.

  4. 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

  5. AF burden at 6 months [ Time Frame: 6 months ]
    AF burden at 6 months

  6. AF burden at 12 months [ Time Frame: 12 months ]
    AF burden at 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 SBP≥160 or DBP≥100 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

Information from the National Library of Medicine

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


Contacts
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Contact: Sam Cammack, MA, MPH 212-824-8931 sam.cammack@mountsinai.org
Contact: Betsy Ellsworth, MSN, ANP 212-824-8902 betsy.ellsworth@mountsinai.org

Locations
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United States, Arizona
Arizona Heart Institute Not yet recruiting
Phoenix, Arizona, United States, 85016
Contact: Sophie Raymond    602-842-7352    sraymond@azheartrhythm.com   
Principal Investigator: Vijendra Swarup, MD         
United States, California
Scripps Clinic Not yet recruiting
La Jolla, California, United States, 92037
Contact: Douglas Gibson, MD         
Principal Investigator: Douglas Gibson, MD         
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Tiffany Hart    773-702-0535    thart@medicine.bsd.uchicago.edu   
Principal Investigator: Roderick Tung, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Kevin Marzotto    617-726-0280    kmarzotto@mgh.harvard.edu   
Contact: Grace Ha    617-726-0280    gha2@mgh.harvard.edu   
Principal Investigator: Moussa Mansour, MD         
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Briita Wanhala    313-916-9575    bwanhal1@hfhs.org   
Principal Investigator: Marc Lahiri, MD         
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: William Whang, MD    212-241-7114    william.whang@mountsinai.org   
Contact: Jonas Leavitt, BS    212-824-8930    jonas.leavitt@mountsinai.org   
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Susan Hejl    216-445-6817    hejls@ccf.org   
Principal Investigator: Mohamed Kanj, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Not yet recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal    512-431-4868    dscardinal@austinheartbeat.com   
Principal Investigator: Andrea Natale, MD         
Czechia
Na Homolce Hospital
Prague, Czechia, 15030
Germany
Herzzentrum Leipzig
Berlin, Brandenburg, Germany, 13347
Universität des Saarlandes Not yet recruiting
Homburg, Germany
Contact: Christina Koch    +49 6841 161 5854    Christina.koch@uks.edu   
Principal Investigator: Christian Ukena, MD         
Sponsors and Collaborators
Vivek Reddy
Investigators
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Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Vivek Reddy, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04182620    
Other Study ID Numbers: IRB 19-02659
IRB 19-02659 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
renal denervation
atrial fibrillation
cardiology
electrophysiology
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes