50 Participants Needed

Renal Denervation + PVI for Atrial Fibrillation

(ERADICATE-AF Trial)

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Overseen ByJonathan Steinberg, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Renal Denervation + PVI for Atrial Fibrillation?

Research shows that Pulmonary Vein Isolation (PVI) is a key part of treating atrial fibrillation (AF) and is recommended for patients with different types of AF. While the benefit of adding other techniques to PVI is unclear, PVI itself is recognized as a potentially curative treatment for AF.12345

Is Renal Denervation + PVI for Atrial Fibrillation safe?

Pulmonary vein isolation (PVI), a key part of the treatment, is generally safe with severe complications occurring in 1-3% of patients. This suggests that while the procedure is mostly safe, there is a small risk of serious complications.13567

How is the treatment Renal Denervation + PVI for Atrial Fibrillation different from other treatments?

Renal Denervation + PVI for Atrial Fibrillation is unique because it combines renal denervation, which targets nerves in the kidneys to help control blood pressure, with pulmonary vein isolation (PVI), a procedure that isolates the pulmonary veins to prevent erratic electrical signals in the heart. This combination aims to enhance the effectiveness of treating atrial fibrillation by addressing both heart rhythm and blood pressure issues.13489

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.

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.
I have had atrial fibrillation symptoms for more than 7 days but less than a year.
See 3 more

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.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulmonary vein isolation (PVI) and may receive additional renal artery denervation (RDN)

Immediate procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety, AF burden, and other clinical outcomes

12 months
Regular visits (in-person and virtual) at 0, 1, 3, 6, and 12 months

Long-term Follow-up

Participants are monitored for long-term outcomes such as AF recurrence and quality of life

Beyond 12 months

Treatment Details

Interventions

  • Catheter Ablation
  • Renal Artery Denervation
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

Patients with atrial fibrillation (AF) who underwent pulmonary vein isolation plus additional atrial ablations (PVI+) had a significantly higher rate of maintaining normal sinus rhythm in the first year compared to those who only had PVI, with a relative risk of 1.10 based on 21 randomized controlled trials and 3 non-randomized trials.
The most notable improvement was seen with PVI+ left atrial linear ablations, which showed a relative risk of 1.16, indicating that this specific approach may enhance the effectiveness of AF treatment.
Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis.Assasi, N., Xie, F., Blackhouse, G., et al.[2021]
A meta-analysis of 8 studies showed that adding complex fractionated atrial electrogram (CFAE) ablation to pulmonary vein isolation (PVI) significantly improves freedom from atrial tachyarrhythmia (AT) in patients with nonparoxysmal atrial fibrillation (AF), with a relative risk of 1.32.
In contrast, for patients with paroxysmal AF, the addition of CFAE ablation did not provide any significant benefit over PVI alone, indicating that this combined approach may be more effective for nonparoxysmal cases.
Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis.Hayward, RM., Upadhyay, GA., Mela, T., et al.[2021]
The novel irrigated multielectrode ablation catheter successfully isolated 100% of targeted pulmonary veins in 25 patients with paroxysmal atrial fibrillation, demonstrating high acute efficacy with a mean procedure time of 110 minutes and no complications.
The procedure was safe, with no cases of acute pulmonary vein stenosis detected, and showed improved efficiency over time, with reduced procedure and fluoroscopy times after a short learning curve.
Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation.Shin, DI., Kirmanoglou, K., Eickholt, C., et al.[2016]

References

Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. [2021]
Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis. [2021]
Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. [2016]
Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. [2018]
Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. [2021]
A new circular mapping-guided approach for endoscopic laser balloon pulmonary vein isolation. [2020]
Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique. [2021]
Duty-cycled multi-electrode radiofrequency vs. conventional irrigated point-by-point radiofrequency ablation for recurrent atrial fibrillation: comparative 3-year data. [2022]
Innovations in atrial fibrillation ablation. [2023]
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