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

Status unconfirmed · Phase 2

Conditions studied: Atrial Fibrillation, Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT01959997

Run by

Meshalkin Research Institute of Pathology of Circulation

People needed

60

Starts

2013-09-01

Expected to finish

2016-09-01

Last updated by the study team

2015-09-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Inability to access renal vasculature
• Main renal arteries < 4 mm in diameter or < 20 mm in length.
• Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
• A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
• Multiple main renal arteries to either kidney
• Unwillingness to participate

Where it is running

• State Research Institute of Circulation Pathology — Novosibirsk, Russia (enrolling)
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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