RecruitingNot ApplicableNCT05116384

Renal Denervation + PVI vs PVI Alone for Persistent AF

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

Sponsor

University of Rochester

Enrollment

50 participants

Start Date

Jul 30, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches for treating persistent atrial fibrillation (AFib) — an irregular heart rhythm: the standard pulmonary vein isolation (PVI) ablation procedure alone versus PVI combined with renal denervation (a procedure that disrupts nerve signals to the kidneys to help lower blood pressure and heart rate). The trial aims to see if adding renal denervation improves long-term rhythm control. **You may be eligible if...** - You are over 18 with symptomatic persistent AFib (lasting more than 7 days but less than 1 year) - Your blood pressure is normal or well-controlled on medication - Your kidney arteries are suitable for the denervation procedure (confirmed by MRI) - You are scheduled for your first AFib ablation procedure - You are willing to have a small heart monitor (implantable loop recorder) placed **You may NOT be eligible if...** - You have had a prior heart ablation procedure - You have paroxysmal AFib (comes and goes on its own) or long-standing persistent AFib (over 1 year) - You have very poor heart function (LVEF under 25%) or severe heart failure - You have had heart surgery within the past 3 months or have a mechanical heart valve - Your kidney arteries are too narrow or short for the procedure 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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