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Procedure

Renal Denervation + PVI for Atrial Fibrillation (ERADICATE-AF Trial)

N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior history of HTN or HTN controlled on medical therapy (defined as SBP <140 mm Hg and DBP <85 mm Hg)
Age > 18 years
Must not have
A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
Paroxysmal AF, or longstanding persistent AF (duration > 1 year)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, 1, 3, 6 and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial showed that combining RDN and PVI can reduce recurrent AF in uncontrolled hypertensives. RDN plus PVI might improve long-term AF control for persistent AF patients.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications from catheter ablation like bleeding or infection at the site of insertion, damage to blood vessels or heart tissue, adverse reactions to anesthesia, and kidney-related issues due to RDN.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood pressure is under control, either naturally or with medication.
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I am older than 18 years.
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My kidney blood vessels can be reached for treatment, as shown by an MRI.
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I am willing to have an ILR device implanted.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had a procedure on my kidney arteries that prevents me from getting ablation treatment.
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I have had atrial fibrillation that comes and goes or has lasted for more than a year.
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I have had a procedure to correct an irregular heartbeat.
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My kidneys have more than one main artery.
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I have had heart valve surgery with a mechanical valve replacement.
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I have a significant kidney artery problem.
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Doctors cannot reach my kidney blood vessels for treatment.
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I cannot have AF catheter ablation due to a heart clot or issues with blood thinners.
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My main kidney arteries are small in size.
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My heart's pumping ability is severely reduced.
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My kidney's blood vessels are not suitable for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, 1, 3, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0, 1, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AF burden
Secondary study objectives
BP changes over time
Cardiac sympathetic nervous system modulation
Number of subject with recurrent atrial fibrillation
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
catheter ablation
2010
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,281 Total Patients Enrolled
46 Trials studying Atrial Fibrillation
539,743 Patients Enrolled for Atrial Fibrillation
University of RochesterLead Sponsor
869 Previous Clinical Trials
549,712 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
5,286 Patients Enrolled for Atrial Fibrillation

Media Library

Catheter Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05116384 — N/A
Atrial Fibrillation Research Study Groups: Pulmonary vein isolation, Pulmonary vein isolation + renal artery denervation
Atrial Fibrillation Clinical Trial 2023: Catheter Ablation Highlights & Side Effects. Trial Name: NCT05116384 — N/A
Catheter Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116384 — N/A
~10 spots leftby Mar 2025
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