Clinical trial NCT05988411: ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation Vs Control in Redo Ablation Patients
Official title: Ultrasound-Based Renal Sympathetic Denervation As Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial.
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Freedom from atrial arrhythmias with no AADs
timeFrame: after 90 days
Secondary outcomes:
measure: Freedom from atrial arrhythmias (AT/AF/AFL) with AADs
timeFrame: at 12 months
measure: Procedure-related adverse events
timeFrame: at 12 months
measure: Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)
timeFrame: at 12 months
measure: Blood pressure
timeFrame: at 12 months
measure: Number of AF episodes
timeFrame: at 12 months
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: San Francisco
country: United States
facility: UCSF
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Medical Center
state: California
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Tyler
country: United States
facility: Christus
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: