Renal Denervation + PVI for Atrial Fibrillation
(ERADICATE-AF Trial)
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.
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?
Is Renal Denervation + PVI for Atrial Fibrillation safe?
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
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo pulmonary vein isolation (PVI) and may receive additional renal artery denervation (RDN)
Follow-up
Participants are monitored for safety, AF burden, and other clinical outcomes
Long-term Follow-up
Participants are monitored for long-term outcomes such as AF recurrence and quality of life
Treatment Details
Interventions
- Catheter Ablation (Procedure)
- Renal Artery Denervation (Procedure)
Catheter Ablation is already approved in European Union, United States, Canada for the following indications:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction