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.
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
2
sites
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Novosibirsk, 63005
Principal Investigator: Evgeny Pokushalov, MD, PhD
Phone: +79139254858
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