Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI

Randomized Comparison of Redo Pulmonary Vein Isolation With vs. Without Renal Denervation for Recurrent Atrial Fibrillation After Initial Pulmonary Vein Isolation

The objective of this study is to compare the elimination of atrial fibrillation in patients with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when undergoing repeat PVI (control) vs repeat PVI plus renal denervation.

Inclusion Criteria:

• Prior PVI ablation procedure for paroxysmal AF within past 2 years
• Recurrent symptomatic paroxysmal AF despite prior PVI
• History of essential hypertension requiring at least 2 chronic antihypertensive medications

Exclusion Criteria:

• Persistent AF after prior ablation

• Congestive heart failure (NYHA III-IV functional class)

• Left ventricle ejection fraction < 35%

• Left atrial diameter >55 mm

• An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation

• Renal arteries unsuitable for RDN:

  1. 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 in either renal artery
  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

• Unwillingness to participate