NCT05116384Recruiting
Renal Denervation + PVI vs PVI Alone for Persistent AF
A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 25 May 2021
- Start date
- 30 Jul 2023
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- University of Rochester
- Diseases
- Atrial fibrillation
- NCT number
- NCT05116384
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 30 Jul 2023 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior left atrial ablation for an atrial arrhythmia
- 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
Other illness
- Life expectancy \<1 year for any medical condition
Lab values
- NYHA class IV congestive heart failure or LVEF \< 25%
- An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
Other
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Paroxysmal AF, or longstanding persistent AF (duration \> 1 year)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Coordinator of this site? Confirm its status | Short Hills | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.