Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation



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:June 2013
End Date:February 2017

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Evaluate Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF) Trial

The objective of this trial is to determine the role of renal sympathetic denervation in the
prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a
catheter-based AF ablation procedure is planned. Patients will be randomized to either AF
catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic
denervation.


Inclusion Criteria:

- Age ≥ 18 years of age

- History of PAF and plans for a guideline-supported catheter ablation procedure.
Paroxysmal AF is defined as AF with duration of 30 secs to 7 days.

- History of significant hypertension (defined as SBP ≥130 mm Hg and/or DBP ≥80 mmHg)
and receiving treatment with at least one anti-hypertensive medication

- Renal vasculature accessible as determined by pre-procedural renal MRA

- Willingness to comply with all post-procedural follow-up requirements and to sign
informed consent

Exclusion Criteria:

- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus,
contraindication to all anticoagulation)

- Prior left atrial ablation for an atrial arrhythmia

- NYHA class IV congestive heart failure

- Pers or longstanding Pers AF (duration > 7 days)

- Renal artery anatomy that is ineligible for treatment

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

- Life expectancy <1 year for any medical condition
We found this trial at
2
sites
Novosibirsk, 63005
Principal Investigator: Evgeny Pokushalov, MD, PhD
Phone: +79139254858
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Novosibirsk,
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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