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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, 1, 3, 6 and 12 months
Awards & highlights
ERADICATE-AF Trial 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.Check my eligibility
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.See study design
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.
ERADICATE-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ERADICATE-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 0, 1, 3, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, 1, 3, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AF burden
Secondary outcome measures
BP changes over time
Cardiac sympathetic nervous system modulation
Number of subject with recurrent atrial fibrillation
+4 moreERADICATE-AF 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
3,840 Previous Clinical Trials
47,852,074 Total Patients Enrolled
45 Trials studying Atrial Fibrillation
539,543 Patients Enrolled for Atrial Fibrillation
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,200 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
5,161 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility 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.My blood pressure is under control, either naturally or with medication.I have had heart valve surgery with a mechanical valve replacement.I have a significant kidney artery problem.You are not expected to live for more than one year because of a medical condition.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.I am older than 18 years.I had heart surgery or a procedure to improve blood flow to the heart within the last 3 months.I have had atrial fibrillation symptoms for more than 7 days but less than a year.My heart's pumping ability is severely reduced.My kidney's blood vessels are not suitable for treatment.My kidney blood vessels can be reached for treatment, as shown by an MRI.I am willing to have an ILR device implanted.Your kidney function is less than 45mL/min/1.73m2 as measured by a specific calculation.
Research Study Groups:
This trial has the following groups:- Group 1: Pulmonary vein isolation
- Group 2: Pulmonary vein isolation + renal artery denervation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently recruiting participants for this experiment?
"Affirmative. Clinicaltrials.gov information reveals that this experiment is currently searching for participants, with the listing first appearing on July 30th 2023 and being revised most recently on August 10th of the same year. 50 patients need to be enlisted from a single medical site."
Answered by AI
How many people are being accepted into this clinical study?
"Affirmative, clinicaltrials.gov attests to the fact that this trial is currently seeking recruits. It was initially posted on July 30th 2023 and recently updated August 10th of the same year. The research team requires 50 patients from one medical facility for enrollment in their study."
Answered by AI
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