Recruiting

Renal Denervation & PVI

Sponsor:

University of Rochester

Code:

NCT05116384

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

catheter ablation

renal artery denervation

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Study ID

NCT05116384

Start date

Jul 30, 2023

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > 18 years
2. Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation > 7 days and up to 1 year)
3. No prior history of HTN or HTN controlled on medical therapy (defined as SBP <140 mm Hg and DBP <85 mm Hg)
4. Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram
5. Willingness to undergo ILR placement
6. Willingness to comply with post-procedural follow-up requirements and to sign informed consent.

Exclusion Criteria:

1. Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
2. Prior left atrial ablation for an atrial arrhythmia
3. NYHA class IV congestive heart failure or LVEF < 25%
4. Paroxysmal AF, or longstanding persistent AF (duration > 1 year)
5. Coronary revascularization or valve surgery within 3 months
6. Prior valve surgery using a mechanical prosthesis
7. Renal artery anatomy that is ineligible for treatment including:

1. Predicted inability to access renal vasculature
2. Main renal arteries < 4 mm in diameter or < 20 mm in length.
3. Hemodynamically or anatomically significant renal artery abnormality or stenosis
4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
5. Multiple main renal arteries to either kidney
8. An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
9. Life expectancy <1 year for any medical condition

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pulmonary vein isolation

Electrical isolation by cryoballoon of all pulmonary veins

experimental: Pulmonary vein isolation + renal artery denervation

After completion of the standard PVI, radiofrequency ablation of bilateral renal arteries

Interventions

catheter ablation

cryo energy via cryoballoon

renal artery denervation

RF energy delivery to multiple sites within each major renal artery

Primary outcome measure

  • AF burden [ Time Frame: At 1 year ]

Central Contacts and Locations

Central contacts

Jonathan Steinberg, MD

9734364155jsteinberg@smgnj.com

Locations

University of Rochester

Recruiting

Short Hills, New Jersey, United States, 07078

Contacts

More Information

Sponsor

University of Rochester

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-12-11.