Renal Denervation + PVI vs PVI Alone for Persistent AF

Launched by UNIVERSITY OF ROCHESTER · Oct 30, 2021

Keywords

ClinConnect Summary

The ERADICATE-AF II trial is studying a new approach to treat persistent atrial fibrillation (AF), a heart condition where the heart beats irregularly. In this trial, researchers want to see if combining two treatments—renal artery denervation (RDN) and pulmonary vein isolation (PVI)—is more effective than using PVI alone. RDN is a procedure that helps calm the nerves around the kidneys that can contribute to AF. This study is specifically looking for patients aged 18 and older who have persistent AF and are either not experiencing high blood pressure or have it well-controlled with medication.

If you participate in this trial, you will undergo an implantable loop recording, which is a small device placed under your skin to monitor your heart's activity over time. It’s essential that you are willing to follow up with the medical team after the procedure. Some key points to consider are that you should not have a history of severe heart failure, certain prior heart procedures, or specific kidney conditions, as these could make you ineligible for the trial. Overall, this study aims to find better long-term solutions for managing persistent AF, helping improve the quality of life for those affected.

Gender

ALL

Eligibility criteria

• 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