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Pulsed Field Ablation System
FARAPULSE Ablation for Atrial Fibrillation (ADVANTAGE AF Trial)
N/A
Waitlist Available
Led By Vivek Reddy
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as: a. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND, within 180 days of Enrollment Date, either: i. A 24-hour continuous ECG recording confirming continuous AF OR ii. Two ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart b. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I or III). c. Persistent: continuous AF for > 7 days and ≤ 365 days
Age ≥ 18 years of age, or older if specified by local law
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 360 days
Awards & highlights
ADVANTAGE AF Trial Summary
This trial is testing a new device to treat atrial fibrillation, a common heart rhythm disorder.
Who is the study for?
This trial is for adults with symptomatic, drug-resistant persistent atrial fibrillation (AF) that's been continuous for more than 7 days but less than a year. Participants must have tried at least one antiarrhythmic drug without success and be able to attend all study-related tests. Exclusions include secondary AF due to reversible causes, severe heart conditions, certain pre-existing medical devices or implants, recent stroke or bleeding events, pregnancy, uncontrolled health issues like diabetes or sleep apnea, and those currently in other conflicting studies.Check my eligibility
What is being tested?
The ADVANTAGE AF Study is testing the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System as a treatment option for people with persistent AF who haven't responded well to drugs. It's an open-label study where all participants receive the same intervention using this new ablation system designed specifically for their condition.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with ablation procedures may include discomfort at the site of catheter insertion, bleeding or bruising there too; rare chances of serious complications such as damage to blood vessels or heart tissue; potential arrhythmias during recovery; and very rarely stroke.
ADVANTAGE AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have persistent AF that's resistant to at least one heart rhythm medication.
Select...
I am at least 18 years old or meet the age requirement by local law.
ADVANTAGE AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 360 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~360 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Rate of Persistent AF Acute Procedural Success
Phase 1: Rate of Persistent AF Chronic Success
Phase 1: Rate of Safety Events at 12 Months Post Procedure
+7 moreADVANTAGE AF Trial Design
2Treatment groups
Experimental Treatment
Group I: Pulsed Field Ablation (Phase 2)Experimental Treatment1 Intervention
PHASE 2 only
Group II: Pulsed Field Ablation (Phase 1)Experimental Treatment1 Intervention
PHASE 1 only
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
932,729 Total Patients Enrolled
69 Trials studying Atrial Fibrillation
28,069 Patients Enrolled for Atrial Fibrillation
Vivek ReddyPrincipal InvestigatorMOUNT SINAI HOSPITAL
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have a LUX-Dx device that was put in more than 6 months ago and is expected to last less than 1 year, you cannot participate.I cannot have a device implanted under my skin for health reasons.I have severe lung disease or need extra oxygen.I have had a stroke, TIA, or brain bleeding.I have a tumor in my heart's left atrium.You currently have a blood clot in your left atrium.My atrial fibrillation is due to a reversible cause like thyroid issues or electrolyte imbalance.I have had a blood clot that was not in my brain.I haven't taken blood thinners for at least 4 weeks before the ablation procedure.I am currently fighting an infection in my body.You are expected to live less than one year.My kidney function is low, with an eGFR below 30, or I have had dialysis or a kidney transplant.I have or had paralysis or weakness of one side of my diaphragm.I have persistent AF that's resistant to at least one heart rhythm medication.- You currently have active COVID-19 or have recently had COVID-19 that hasn't fully cleared up.
- Your diabetes is not well controlled, or your HgbA1c test result is higher than 8.0% in the last 3 months.
- You have severe untreated obstructive sleep apnea, with more than 30 pauses in breathing per hour.Your heart's pumping function is less than 40%.I am at least 18 years old or meet the age requirement by local law.I am willing and able to give my consent for treatment.You have a pacemaker, implantable cardioverter defibrillator, or other heart devices in place.I have had heart surgery.I do not have severe stomach or esophagus problems.You have a known condition called congenital methemoglobinemia.I have a known G6PD deficiency.I have had a heart rhythm correction procedure, but not for conditions affecting the right side of my heart.I have had issues with my blood vessels, but not with the common or middle ones.I have not had cancer, except for skin cancer, in the last 2 years.You have heart valve disease, hypertrophic cardiomyopathy, or certain heart conditions that could cause problems during the study.I have had or am being evaluated for an organ or bone marrow transplant.I have severe heart failure.I am not pregnant, breastfeeding, and I use birth control.I have a heart condition from birth with lasting effects.I am willing and able to attend all tests at the clinical trial center.I have a blood condition affecting clotting or platelet levels.I have had bleeding in my stomach or intestines.I have had a procedure to open my carotid artery.My heart's left atrium is enlarged.I have never had sustained ventricular tachycardia or ventricular fibrillation.Your blood pressure is very high and not well-controlled, with two separate readings showing high numbers.I have had a heart attack, unstable chest pain, or heart procedure in the last 3 months.I have been hospitalized for heart failure.I have inflammation or fluid around my heart.I cannot or do not want to use blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed Field Ablation (Phase 1)
- Group 2: Pulsed Field Ablation (Phase 2)
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 it possible to sign up for this medical experiment currently?
"According to clinicaltrials.gov, this study is still recruiting participants and was first launched on March 2nd 2023 with the most recent update occuring on the same day."
Answered by AI
How many participants are actively engaged in the research project?
"The sponsor, Boston Scientific Corporation will be managing this medical trial from multiple locations including Banner University Medical Centre Phoenix-Hospital in Arizona and Arrhythmia Research Group-Research Facility in Arkansas. To successfully conclude the study, a total of 417 qualified patients must take part."
Answered by AI
Are there a great number of hospitals running this trial across North America?
"The following medical centres are actively recruiting for this study: Banner University Medical Center Phoenix-Hospital located in Phoenix, Arizona; Arrhythmia Research Group-Research Facility situated in Jonesboro, Arkansas; and Scripps Memorial Hospital-Hospital found in La Jolla, California. There are another 53 sites that have opened recruitment to participants as well."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
NYU Langone Health Heart Rhythm Center
Bethesda North Hospital-Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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