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

Status:	Recruiting
Conditions:	Atrial Fibrillation, High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	4/21/2016
Start Date:	September 2013
End Date:	September 2016
Contact:	Evgeny Pokushalov, MD, PhD
Email:	e.pokushalov@gmail.com
Phone:	+79139254858

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

We found this trial at

sites

State Research Institute of Circulation Pathology

Novosibirsk, 63005

Principal Investigator: Evgeny Pokushalov, MD, PhD

Phone: +79139254858

from

Novosibirsk,