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Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation

NCT04182620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-05-08

No results posted yet for this study

Summary

The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Conditions

Interventions

DEVICE

renal denervation

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

DEVICE

Catheter ablation

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

Sponsors & Collaborators

  • Vivek Reddy

    lead OTHER

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2025-02-26
Completion
2025-02-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182620 on ClinicalTrials.gov