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Trial record 2 of 2 for:    ultra-hfib
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ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients

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ClinicalTrials.gov Identifier: NCT05988411
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Study Description
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Brief Summary:
This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Device: Renal Denervation Device: Catheter Ablation Not Applicable

Detailed Description:
This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 20 clinical sites in the United States. Once the clinical sites are up and running (expected to take 6 months), accrual is expected to take an additional 9 months, and all patients will be followed for 12 months post randomization. Patients, the Clinical Events Committee and the ECG core lab will be blinded during the trial. Patients will be unblinded at the 12-month visit.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial.
Masking: Single (Participant)
Masking Description: single-blind
Primary Purpose: Treatment
Official Title: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: A Pilot Study
Actual Study Start Date : December 7, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Renal Denervation (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.


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from atrial arrhythmias with no AADs [ Time Frame: after 90 days ]
    Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).


Secondary Outcome Measures :
  1. Freedom from atrial arrhythmias (AT/AF/AFL) with AADs [ Time Frame: at 12 months ]
    Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs

  2. Procedure-related adverse events [ Time Frame: at 12 months ]
    Number of procedure-related adverse events

  3. Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT) [ Time Frame: at 12 months ]
    Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.

  4. Blood pressure [ Time Frame: at 12 months ]
    Blood pressure - Systolic and Diastolic

  5. Number of AF episodes [ Time Frame: at 12 months ]
    AF burden assessed by the amount of AF episodes detected during Event Monitoring


Eligibility Criteria
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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;
  • Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, 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). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)

  • 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); >3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.
  • Individual with valvular AF or AF due to a reversible cause
  • 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 renal angiography);

    • Main renal artery diameter <3mm 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%
    • 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 protocol.
Contacts and Locations
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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): NCT05988411


Contacts
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Contact: Jeff Lam, MS (212) 824-8929 jeff.lam@mountsinai.org
Contact: Betsy Ellsworth, MSN ANP (212) 824-8902 betsy.ellsworth@mountsinai.org

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Jeff Lam, MS    212-824-8929    jeff.lam@mountsinai.org   
Contact: Betsy Ellsworth, MSN ANP    (212) 824-8902    betsy.ellsworth@mountsinai.org   
Principal Investigator: Abhishek Maan         
Sponsors and Collaborators
Vivek Reddy
Investigators
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Principal Investigator: Vivek Reddy, MD MOUNT SINAI HOSPITAL
More Information
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Responsible Party: Vivek Reddy, Professor of Medicine , Director, Cardiac Electrophysiology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT05988411    
Other Study ID Numbers: BRANY 23-02-344
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes