ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988411
• Other study ID #: BRANY 23-02-344
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Jeff Lam, MS
• Phone: (212) 824-8929
• Email: jeff.lam[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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
• Catheter Ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vivek Reddy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial arrhythmias with no AADs	Freedom from atrial arrhythmias (AT/AF/AFL) recurrence = 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).	after 90 days
Secondary	Freedom from atrial arrhythmias (AT/AF/AFL) with AADs	Freedom from AT/AF/AFL recurrence = 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs	at 12 months
Secondary	Procedure-related adverse events	Number of procedure-related adverse events	at 12 months
Secondary	Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)	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.	at 12 months
Secondary	Blood pressure	Blood pressure - Systolic and Diastolic	at 12 months
Secondary	Number of AF episodes	AF burden assessed by the amount of AF episodes detected during Event Monitoring	at 12 months