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

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

sites

State Research Institute of Circulation Pathology

Novosibirsk, 63005

Principal Investigator: Evgeny Pokushalov, MD, PhD

Phone: +79139254858

from

Novosibirsk,