Ultrasound-based treatment for atrial fibrillation recurrence in patients needing redo ablation

Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: A Pilot Study

This study is testing if adding a special kidney treatment to standard heart procedures can help people with high blood pressure who are having a repeat procedure for atrial fibrillation experience fewer heart rhythm problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 8 sites (Jonesboro, Arkansas and 7 other locations)
• Trial ID: NCT05988411 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of adding renal sympathetic denervation to standard atrial fibrillation (AF) ablation procedures in patients with hypertension who are scheduled for a redo AF ablation. It is a prospective, controlled, single-blind, randomized trial with a 2:1 allocation of participants to either the intervention group receiving both AF ablation and renal denervation or a control group receiving only AF ablation. The study will take place across up to 20 clinical sites in the United States, with patient follow-up lasting 12 months post-randomization to assess recurrence of AF. The trial aims to provide insights into whether this adjunctive treatment can reduce AF recurrence rates in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of hypertension and scheduled for a redo AF ablation procedure.

Not a fit: Patients with long-standing persistent atrial fibrillation or those who have had more than three prior ablation procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of atrial fibrillation in patients undergoing redo ablation, improving their long-term heart health.

How similar studies have performed: While the specific combination of renal sympathetic denervation and redo AF ablation is novel, similar approaches in managing atrial fibrillation have shown promise in other studies.

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.

Where this trial is running

Jonesboro, Arkansas and 7 other locations

• Arrhythmia Research Group — Jonesboro, Arkansas, United States (Recruiting)
• UCSF — San Francisco, California, United States (Recruiting)
• Los Robles Medical Center — Thousand Oaks, California, United States (Recruiting)
• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
• Mount Sinai Hospital — New York, New York, United States (Recruiting)
• Trident Medical Center — Charleston, South Carolina, United States (Recruiting)
• Christus — Tyler, Texas, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Vivek Reddy, MD — Mount Sinai Hospital
• Study coordinator: Jeff Lam, MS

Conditions Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation