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RECRUITING
NCT05116384
NA

Renal Denervation + PVI vs PVI Alone for Persistent AF

Sponsor: University of Rochester

View on ClinicalTrials.gov

Summary

Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives. This is a randomized controlled pilot trial, "To Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II) to test if RDN plus PVI enhances long-term efficacy vs PVI for persistent AF patients with controlled or without hypertension using implantable loop recordings.

Official title: A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-07-30

Completion Date

2026-06-30

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DEVICE

catheter ablation

cryo energy via cryoballoon

DEVICE

renal artery denervation

RF energy delivery to multiple sites within each major renal artery

Locations (1)

University of Rochester

Short Hills, New Jersey, United States