Atrial FibrillationERADICATE-AFNCT05116384
Renal Denervation + PVI vs PVI Alone for Persistent AF
A study testing catheter ablation and renal artery denervation in people with Atrial Fibrillation, run by University of Rochester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- catheter ablation and renal artery denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Short Hills, New Jersey, 07078
Jonathan Steinberg, 9734364155, jsteinberg@smgnj.com
About this study
Official title: A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation
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.
Read the detailed description
Pulmonary vein isolation (PVI) is the cornerstone of ablation strategies for atrial fibrillation (AF) and is the only cardio-centric approach consistently shown to be effective for reducing arrhythmia recurrence and improving symptom status. Catheter ablation is superior to medical therapy and current antiarrhythmic drug options are limited, can have significant adverse effects, and are associated with a high arrhythmia recurrence rate, especially for persistent AF. Catheter ablation is now commonly prescribed for symptomatic AF patients who do not respond to medications and carries a class II indication. Thousands of patients undergo catheter ablation in the US each year. Nonetheless, even with technical advances, PVI has a recognized and significant rate of short- and long-term failure, and often requires multiple procedures to establish success.
The mechanisms of AF are diverse, but increased central sympathetic outflow and efferent cardiac sympathetic nerve stimulation can lead to enhanced automaticity and triggered activity, and thus contribute to the development and perpetuation of AF. Reduction in cardiac sympathetic input has been proposed as a logical adjunctive approach to PVI but its technical application via cardiac ablation (targeting autonomic ganglia) has had mixed results at best.
The therapeutic objective of lesser cardiac sympathetic stimulation can be potentially accomplished by renal artery denervation (RDN), a technique originally developed for the treatment of resistant hypertension. RDN's potential for antiarrhythmic effect may be mediated by reduced central nervous sympathetic output and is exemplified by a decrease in whole-body norepinephrine spillover and muscle-sympathetic nerve activity.
The recently completed large-scale, randomized, multicenter, single-blind clinical trial, ERADICATE-AF, demonstrated that RDN plus PVI resulted in a relative 43% reduction (absolute change, 15%; P < 0.001) in recurrent incident AF during one year of follow-up. The trial enrolled > 300 patients with paroxysmal AF referred for ablation, all with poorly controlled hypertension despite medication. There was no difference in complications between the 2 groups, and the procedure with RDN was only lengthened by about 24 minutes.
The trial results suggested that a strategy of reducing cardiac autonomic input is an effective antiarrhythmic approach, in line with many preclinical models. It also represents a paradigm of the potential for complementary noncardiac ablation that is effective and safe when coupled with PVI. Until now, this approach has only been tested in patients with resistant and/or poorly controlled hypertension.
A randomized controlled pilot clinical trial has been proposed: "A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II), to test the hypothesis that RDN in addition to PVI enhances long-term antiarrhythmic efficacy in comparison to PVI alone for patients with persistent AF with controlled hypertension or without hypertension in a multicenter, single-blinded, longitudinal randomized clinical trial. The trial will be advantaged by performing implantable loop recordings (ILR) in all patients, which will facilitate the calculation of AF burden, now recognized as a powerful predictor of clinical outcome. With successful completion of this pilot program, we hope to launch a large-scale trial with cardiovascular and death events as endpoints.
The primary aim of the study:
To determine if patients with persistent AF with controlled hypertension or without hypertension who are referred for catheter ablation (PVI) and undergo adjunctive RDN have reduced AF burden at 12 months in comparison to patients who undergo only PVI
The following secondary aims will be tested:
In patients with persistent AF with controlled hypertension or without hypertension who are referred for catheter ablation (PVI) and undergo adjunctive RDN relative to patients who undergo only PVI:
- To assess safety, blood pressure and autonomic nervous system outcomes
- Procedural complications rates
- Postural blood pressure changes over time
- Ambulatory blood pressure monitor results
- Cardiac sympathetic nervous system modulation
- To evaluate clinical end points
- Frequency of progression to recurrent persistent AF
- Referral for repeat catheter ablation of AF
- Need for cardiovascular emergency room visits and hospitalizations
- To measure effects on quality of life
- Conditions
- Atrial Fibrillation
- Being tested
- catheter ablation, renal artery denervation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablationDevice
cryo energy via cryoballoon
renal artery denervationDevice
RF energy delivery to multiple sites within each major renal artery
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Electrical isolation by cryoballoon of all pulmonary veins Receives: Device: catheter ablation |
| Pulmonary vein isolation + renal artery denervation | Experimental | After completion of the standard PVI, radiofrequency ablation of bilateral renal arteries Receives: Device: catheter ablation; Device: renal artery denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden
The calculated total amount of time in AF after 3-month blanking period
Measured: At 1 year
Secondary outcomes (10)
Procedural complications, radiation exposure, and duration
Adverse events
Measured: 30 days and 12 months
BP changes over time
Orthostatic BP measurements
Measured: At 0, 1, 3, 6 and 12 months
BP changes over time
Ambulatory BP monitoring
Measured: 6 months vs baseline
Cardiac sympathetic nervous system modulation
Heart rate variability
Measured: At 0, 1, 3, 6 and 12 months
Cardiac sympathetic nervous system modulation
ECG-based biomarker: period repolarization dynamics (beat-to-beat variation of T wave vector)
Measured: At 0, 1, 3, 6 and 12 months
Quality of life in response to ablation
Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT); Overall scores ranging from 0-100 (100 best)
Measured: 6 months vs baseline
Quality of life in response to ablation
Short-Form (SF)-12 questionnaire; Overall scores ranging from 0-100 (100 best)
Measured: 6 months vs baseline
Number of subject with recurrent atrial fibrillation
Persistent AF; repeat ablation
Measured: From date of randomized procedure to 12 months
Number of subjects with CV hospitalization and/or ER visits
Clinical events
Measured: From date of randomized procedure to 12 months
Total mortality rate
Death events
Measured: From date of randomized procedure to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start30 Jul 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jonathan Steinberg, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116384
- Sponsor's protocol ID
- UR ERADICATE-AF II
- Other IDs
- R34HL153579
- Acronym
- ERADICATE-AF
- Status last verified
- Dec 2025
- First submitted
- 25 May 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31961420
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05116384
- Acronym / sponsor ID
- ERADICATE-AF / UR ERADICATE-AF II
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pulmonary vein isolation (PVI) is the cornerstone of ablation strategies for atrial fibrillation (AF) and is the only cardio-centric approach consistently shown to be effective for reducing arrhythmia recurrence and improving symptom status. Catheter ablation is superior to medical therapy and current antiarrhythmic drug options are limited, can have significant adverse effects, and are associated with a high arrhythmia recurrence rate, especially for persistent AF. Catheter ablation is now commonly prescribed for symptomatic AF patients who do not respond to medications and carries a class II indication. Thousands of patients undergo catheter ablation in the US each year. Nonetheless, even with technical advances, PVI has a recognized and significant rate of short- and long-term failure, and often requires multiple procedures to establish success.
The mechanisms of AF are diverse, but increased central sympathetic outflow and efferent cardiac sympathetic nerve stimulation can lead to enhanced automaticity and triggered activity, and thus contribute to the development and perpetuation of AF. Reduction in cardiac sympathetic input has been proposed as a logical adjunctive approach to PVI but its technical application via cardiac ablation (targeting autonomic ganglia) has had mixed results at best.
The therapeutic objective of lesser cardiac sympathetic stimulation can be potentially accomplished by renal artery denervation (RDN), a technique originally developed for the treatment of resistant hypertension. RDN's potential for antiarrhythmic effect may be mediated by reduced central nervous sympathetic output and is exemplified by a decrease in whole-body norepinephrine spillover and muscle-sympathetic nerve activity.
The recently completed large-scale, randomized, multicenter, single-blind clinical trial, ERADICATE-AF, demonstrated that RDN plus PVI resulted in a relative 43% reduction (absolute change, 15%; P < 0.001) in recurrent incident AF during one year of follow-up. The trial enrolled > 300 patients with paroxysmal AF referred for ablation, all with poorly controlled hypertension despite medication. There was no difference in complications between the 2 groups, and the procedure with RDN was only lengthened by about 24 minutes.
The trial results suggested that a strategy of reducing cardiac autonomic input is an effective antiarrhythmic approach, in line with many preclinical models. It also represents a paradigm of the potential for complementary noncardiac ablation that is effective and safe when coupled with PVI. Until now, this approach has only been tested in patients with resistant and/or poorly controlled hypertension.
A randomized controlled pilot clinical trial has been proposed: "A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II), to test the hypothesis that RDN in addition to PVI enhances long-term antiarrhythmic efficacy in comparison to PVI alone for patients with persistent AF with controlled hypertension or without hypertension in a multicenter, single-blinded, longitudinal randomized clinical trial. The trial will be advantaged by performing implantable loop recordings (ILR) in all patients, which will facilitate the calculation of AF burden, now recognized as a powerful predictor of clinical outcome. With successful completion of this pilot program, we hope to launch a large-scale trial with cardiovascular and death events as endpoints.
The primary aim of the study:
To determine if patients with persistent AF with controlled hypertension or without hypertension who are referred for catheter ablation (PVI) and undergo adjunctive RDN have reduced AF burden at 12 months in comparison to patients who undergo only PVI
The following secondary aims will be tested:
In patients with persistent AF with controlled hypertension or without hypertension who are referred for catheter ablation (PVI) and undergo adjunctive RDN relative to patients who undergo only PVI:
- To assess safety, blood pressure and autonomic nervous system outcomes
- Procedural complications rates
- Postural blood pressure changes over time
- Ambulatory blood pressure monitor results
- Cardiac sympathetic nervous system modulation
- To evaluate clinical end points
- Frequency of progression to recurrent persistent AF
- Referral for repeat catheter ablation of AF
- Need for cardiovascular emergency room visits and hospitalizations
- To measure effects on quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Device: catheter ablationElectrical isolation by cryoballoon of all pulmonary veins |
| Pulmonary vein isolation + renal artery denervation | Experimental | Device: catheter ablation, Device: renal artery denervationAfter completion of the standard PVI, radiofrequency ablation of bilateral renal arteries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter ablationcryo energy via cryoballoon | Device | Pulmonary vein isolation, Pulmonary vein isolation + renal artery denervation |
| renal artery denervationRF energy delivery to multiple sites within each major renal artery | Device | Pulmonary vein isolation + renal artery denervation |
Primary outcome
AF burden
Time frame: At 1 year
The calculated total amount of time in AF after 3-month blanking period
10 secondary outcomes
Procedural complications, radiation exposure, and duration
Time frame: 30 days and 12 months
BP changes over time
Time frame: At 0, 1, 3, 6 and 12 months
BP changes over time
Time frame: 6 months vs baseline
Cardiac sympathetic nervous system modulation
Time frame: At 0, 1, 3, 6 and 12 months
Cardiac sympathetic nervous system modulation
Time frame: At 0, 1, 3, 6 and 12 months
Quality of life in response to ablation
Time frame: 6 months vs baseline
Quality of life in response to ablation
Time frame: 6 months vs baseline
Number of subject with recurrent atrial fibrillation
Time frame: From date of randomized procedure to 12 months
Number of subjects with CV hospitalization and/or ER visits
Time frame: From date of randomized procedure to 12 months
Total mortality rate
Time frame: From date of randomized procedure to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Results publication: PubMed 31961420Steinberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter ablation and renal artery denervation in people with Atrial Fibrillation, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Steinberg, MD (9734364155, jsteinberg@smgnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF burden (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05116384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.