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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 3

Conditions: Hypertension; Atrial Fibrillation

Treatments: Procedure: renal sympathetic denervation; Procedure: catheter ablation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01873352

RADCA01

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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302 participants in 2 patient groups

CA+RD

Active Comparator group

Description:

Catheter ablation of atrial fibrillation plus renal sympathetic denervation

Treatment:

Procedure: renal sympathetic denervation

Procedure: catheter ablation

CA (control)

Active Comparator group

Description:

Catheter ablation of atrial fibrillation (control group)

Treatment:

Procedure: catheter ablation