Clinical trial NCT01873352: Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation
Official title: Evaluate Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Hypertension
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-06-10
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs
timeFrame: 12 months
measure: Blood pressure control between the two groups as compared to baseline
timeFrame: 6 months
measure: Blood pressure control between the two groups as compared to baseline
timeFrame: 12 months
measure: Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size
timeFrame: 12 months
measure: Procedure adverse events
timeFrame: 12 months
measure: Major adverse cardiac events (defined as a composite of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion)
timeFrame: 12 months
measure: Serious adverse events throughout follow-up
timeFrame: 12 months
measure: Total number of anti-hypertensive medications at study end, compared between the two treatment arms
timeFrame: 12 months
Other outcomes:
Locations:
city: Short Hills
country: United States
facility: Jonathan S. Steinberg
state: New Jersey
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Jonathan S. Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinberg JS, Shabanov V, Ponomarev D, Losik D, Ivanickiy E, Kropotkin E, Polyakov K, Ptaszynski P, Keweloh B, Yao CJ, Pokushalov EA, Romanov AB. Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):248-255. doi: 10.1001/jama.2019.21187.