Renal Denervation + PVI vs PVI Alone for Persistent AF

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Renal Denervation + PVI vs PVI Alone for Persistent AF

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Short Hills

University of Rochester, Short Hills, New Jersey, United States, 07078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

Study Record Dates

2025-03-31