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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


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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