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

Phase 3

Completed

• Conditions: Atrial Fibrillation; Hypertension

• Registration Number: NCT01873352
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-10
• Study Start: 2013-06-20
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds	12 months

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Jonathan S. Steinberg; 🇺🇸 Short Hills, New Jersey, United States

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation