Renal Denervation + PVI vs PVI Alone for Persistent AF
ERADICATE-AF
A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation
2 other identifiers
interventional
50
1 country
1
Brief Summary
Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives. This is a randomized controlled pilot trial, "To Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II) to test if RDN plus PVI enhances long-term efficacy vs PVI for persistent AF patients with controlled or without hypertension using implantable loop recordings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Jul 2023
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 11, 2025
December 1, 2025
2.9 years
May 25, 2021
December 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
AF burden
The calculated total amount of time in AF after 3-month blanking period
At 1 year
Secondary Outcomes (10)
Procedural complications, radiation exposure, and duration
30 days and 12 months
BP changes over time
At 0, 1, 3, 6 and 12 months
BP changes over time
6 months vs baseline
Cardiac sympathetic nervous system modulation
At 0, 1, 3, 6 and 12 months
Cardiac sympathetic nervous system modulation
At 0, 1, 3, 6 and 12 months
- +5 more secondary outcomes
Study Arms (2)
Pulmonary vein isolation
ACTIVE COMPARATORElectrical isolation by cryoballoon of all pulmonary veins
Pulmonary vein isolation + renal artery denervation
EXPERIMENTALAfter completion of the standard PVI, radiofrequency ablation of bilateral renal arteries
Interventions
cryo energy via cryoballoon
RF energy delivery to multiple sites within each major renal artery
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation \> 7 days and up to 1 year)
- No prior history of HTN or HTN controlled on medical therapy (defined as SBP \<140 mm Hg and DBP \<85 mm Hg)
- Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram
- Willingness to undergo ILR placement
- Willingness to comply with post-procedural follow-up requirements and to sign informed consent.
You may not qualify if:
- 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 or LVEF \< 25%
- Paroxysmal AF, or longstanding persistent AF (duration \> 1 year)
- Coronary revascularization or valve surgery within 3 months
- Prior valve surgery using a mechanical prosthesis
- Renal artery anatomy that is ineligible for treatment including:
- Predicted inability to access renal vasculature
- Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis
- A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
- Multiple main renal arteries to either kidney
- An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
- Life expectancy \<1 year for any medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Short Hills, New Jersey, 07078, United States
Related Publications (1)
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.
PMID: 31961420RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine (adj)
Study Record Dates
First Submitted
May 25, 2021
First Posted
November 11, 2021
Study Start
July 30, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share