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

Status Recruiting

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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05988411
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact	Jeff Lam, MS
Phone	(212) 824-8929
Email	jeff.lam@mountsinai.org
Status	Recruiting
Phase	N/A
Start date	December 7, 2023
Completion date	December 2024

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms