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

Meshalkin Research Institute of Pathology of Circulation2 sites in 2 countries302 target enrollmentJune 20, 2013

ConditionsAtrial Fibrillation Hypertension

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 302
Locations: 2
Primary Endpoint: AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 20, 2013

End Date

March 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds

Time Frame: 12 months

Secondary Outcomes

Blood pressure control between the two groups as compared to baseline(12 months)
Major adverse cardiac events (defined as a composite of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion)(12 months)
Total number of anti-hypertensive medications at study end, compared between the two treatment arms(12 months)
Procedure adverse events(12 months)
Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs(12 months)
Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size(12 months)
Serious adverse events throughout follow-up(12 months)