RecruitingNot ApplicableNCT05988411

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

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

Sponsor

Vivek Reddy

Enrollment

250 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding ultrasound-based renal denervation — a minimally invasive procedure that calms overactive nerve signals in the kidney — to a repeat heart rhythm (atrial fibrillation) ablation procedure can improve outcomes for people whose atrial fibrillation came back after their first ablation. **You may be eligible if...** - You are 18 years or older - You have atrial fibrillation (paroxysmal or persistent) that has returned after a previous ablation procedure - You are scheduled for a repeat ablation **You may NOT be eligible if...** - You have not had a previous atrial fibrillation ablation - Your atrial fibrillation is a first-time occurrence - You have specific anatomical or health conditions that prevent renal denervation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERenal Denervation

Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (RDN) catheter that delivers a circumferential ring of ablative ultrasound energy

DEVICECatheter Ablation

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