Renal Denervation + PVI for Atrial Fibrillation (ERADICATE-AF Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Rochester
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Is the treatment Catheter Ablation a promising treatment for Atrial Fibrillation?Yes, Catheter Ablation, specifically Pulmonary Vein Isolation (PVI), is a promising treatment for Atrial Fibrillation. It is widely accepted and recommended for helping patients maintain a normal heart rhythm and relieve symptoms.23469
What data supports the idea that Renal Denervation + PVI for Atrial Fibrillation is an effective treatment?The available research shows that Pulmonary Vein Isolation (PVI) is a key part of treating atrial fibrillation. It is often combined with other techniques to improve results. While the studies focus on PVI, they highlight its importance in managing atrial fibrillation, suggesting that combining it with other methods like Renal Denervation could be beneficial. However, specific data on the combination of Renal Denervation and PVI is not provided in the available research.12367
What safety data exists for Renal Denervation + PVI for Atrial Fibrillation?The safety data for Pulmonary Vein Isolation (PVI), a key component of catheter ablation for atrial fibrillation, indicates that severe complications occur in 1-3% of patients. Various studies have explored different techniques and tools for PVI, such as endoscopic laser balloon ablation and cryoballoon ablation, suggesting these methods are feasible and safe. However, specific safety data for the combination of Renal Denervation with PVI is not directly addressed in the provided research.23578
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop your current medications. However, since it involves procedures like renal denervation and catheter ablation, it's best to discuss your current medications with the trial team.
Eligibility Criteria
This trial is for adults over 18 with symptomatic persistent atrial fibrillation, which lasts more than 7 days but less than a year. Participants can either have no history of hypertension or controlled hypertension. They must be eligible for PVI, have renal arteries suitable for denervation, and agree to heart monitoring and follow-up requirements.Inclusion Criteria
My blood pressure is under control, either naturally or with medication.
I am older than 18 years.
My kidney blood vessels can be reached for treatment, as shown by an MRI.
I am willing to have an ILR device implanted.
Exclusion Criteria
I've had a procedure on my kidney arteries that prevents me from getting ablation treatment.
I have had atrial fibrillation that comes and goes or has lasted for more than a year.
I have had a procedure to correct an irregular heartbeat.
My kidneys have more than one main artery.
I have had heart valve surgery with a mechanical valve replacement.
I have a significant kidney artery problem.
Doctors cannot reach my kidney blood vessels for treatment.
I cannot have AF catheter ablation due to a heart clot or issues with blood thinners.
My main kidney arteries are small in size.
My heart's pumping ability is severely reduced.
My kidney's blood vessels are not suitable for treatment.
Treatment Details
The study is testing if adding renal artery denervation (RDN) to the standard catheter ablation treatment called pulmonary vein isolation (PVI) improves outcomes in patients with persistent atrial fibrillation. It's a randomized pilot trial where some participants will receive both treatments while others only PVI.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pulmonary vein isolation + renal artery denervationExperimental Treatment2 Interventions
After completion of the standard PVI, radiofrequency ablation of bilateral renal arteries
Group II: Pulmonary vein isolationActive Control1 Intervention
Electrical isolation by cryoballoon of all pulmonary veins
Catheter Ablation is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Pulmonary Vein Isolation (PVI) for:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
🇺🇸 Approved in United States as Pulmonary Vein Isolation (PVI) for:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
🇨🇦 Approved in Canada as Pulmonary Vein Isolation (PVI) for:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of RochesterShort Hills, NJ
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Who is running the clinical trial?
University of RochesterLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis. [2021]Pulmonary vein isolation (PVI) is recognized as a potentially curative treatment for atrial fibrillation (AF). Ablation of complex fractionated atrial electrograms (CFAEs) in addition to PVI has been advocated as a means to improve procedural outcomes, but the benefit remains unclear.
Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. [2021]Pulmonary vein isolation (PVI) forms the basis of catheter ablation strategies for atrial fibrillation (AF). Ablation of additional sites has been used to increase the efficacy of ablation procedures in restoring and maintaining normal sinus rhythm.
Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. [2016]Pulmonary vein isolation (PVI) as a cornerstone for catheter ablation of atrial fibrillation (AF) remains a complex and time-consuming procedure.
Duty-cycled multi-electrode radiofrequency vs. conventional irrigated point-by-point radiofrequency ablation for recurrent atrial fibrillation: comparative 3-year data. [2022]Pulmonary vein isolation (PVI) is an accepted treatment to relieve symptoms in patients with atrial fibrillation (AF). We studied 3 year outcome after PVI guided by duty-cycled multi-electrode radiofrequency (RF) ablation (pulmonary vein ablation catheter, PVAC) and provided comparative data to outcome after conventional PVI (CPVI) using mapping with irrigated, point-per-point RF ablation.
A new circular mapping-guided approach for endoscopic laser balloon pulmonary vein isolation. [2020]Pulmonary vein isolation (PVI) for atrial fibrillation (AF) is performed with the endoscopically assisted laser balloon ablation system (EAS). We hypothesized that placement of a circular mapping catheter (CMC) in the pulmonary vein (PV) distal to the laser balloon during ablation is feasible and safe.
Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. [2018]Pulmonary vein isolation (PVI) is a cornerstone ablation strategy in the management of patients with atrial fibrillation (AF). Consensus guidelines and statements recommend PVI during the index catheter ablation procedure in patients with paroxysmal and persistent AF.
Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. [2021]Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF).
Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique. [2021]Pulmonary vein isolation (PVI) has become a cornerstone of the invasive treatment of atrial fibrillation. Severe complications are reported in 1-3% of patients. This study aims to compare complications and follow-up outcome of PVI in patients with atrial fibrillation.
Innovations in atrial fibrillation ablation. [2023]Catheter-based ablation to perform pulmonary vein isolation (PVI) has established itself as a mainstay in the rhythm control strategy of atrial fibrillation. This review article aims to provide an overview of recent advances in atrial fibrillation ablation technology.