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Pulsed Field Ablation System

FARAPULSE PFA vs Standard Ablation for Atrial Fibrillation (ADVENT Trial)

N/A
Waitlist Available
Led By Vivek Reddy, MD
Research Sponsored by Farapulse, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
Paroxysmal atrial fibrillation
Must not have
Diagnosed disorder of blood clotting or bleeding diathesis
AF that is persistent or requires frequent cardioversions, or is secondary to reversible/non-cardiac causes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial is testing a new ablation system for treating PAF. It is compared to the current standard of care, which uses force-sensing RF catheters and cryoballoon catheters.

Who is the study for?
This trial is for adults aged 18-75 with paroxysmal atrial fibrillation (PAF) who haven't responded to anti-arrhythmic drugs. Participants must be able to consent and follow study procedures. Exclusions include pregnancy, other clinical study involvement, certain heart conditions or procedures, blood disorders, uncontrolled medical issues, and severe sleep apnea.Check my eligibility
What is being tested?
The FARAPULSE Pulsed Field Ablation System is being tested against the standard of care ablation using force-sensing RF catheters and cryoballoon catheters in patients with PAF. It's a head-to-head comparison to see which treatment works better for controlling irregular heartbeats.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of ablation, bleeding or bruising, risk of infection from the procedure, possible damage to surrounding heart tissue or vessels leading to complications like arrhythmias or pericarditis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It seems like the criterion is incomplete. Could you please provide more details or the full text of the criterion so that I can assist you accurately?
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I have episodes of irregular heartbeat.
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My heart rhythm medication did not work or caused side effects.
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I am between 18 and 75 years old.
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My atrial fibrillation symptoms persist despite trying medications.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a diagnosed blood clotting or bleeding disorder.
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My atrial fibrillation is persistent or often needs resetting.
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I cannot receive blood thinners or undergo CT/MRI scans.
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I currently have an infection or COVID-19.
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I have sleep apnea or my doctor thinks I have less than a year to live.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Safety Endpoint;Proportion of Intent to Treat Subjects with one or more of the specified device or procedure related SAEs
Primary Effectiveness Endpoint
Treatment success
Secondary outcome measures
PV Diameter change
Secondary Effectiveness Endpoint
Treatment Superiority

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FARAPULSE Pulsed Field Ablation SystemExperimental Treatment1 Intervention
Group II: Force Sensing Radiofrequency Ablation and Cryoballoon AblationActive Control1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Atrial Fibrillation (AF) include antiarrhythmic drugs, electrical cardioversion, and catheter ablation. Antiarrhythmic drugs work by modifying the electrical signals in the heart to maintain a normal rhythm. Electrical cardioversion uses controlled electric shocks to reset the heart's rhythm. Catheter ablation, including the FARAPULSE Pulsed Field Ablation System, targets and destroys small areas of heart tissue that cause irregular electrical signals, using methods such as radiofrequency, cryotherapy, or pulsed electric fields. These treatments are crucial for AF patients as they help restore and maintain normal heart rhythm, reduce symptoms, and prevent complications such as stroke.
Contemporary Diagnosis and Management of Atrial Flutter: A Continuum of Atrial Fibrillation and Vice Versa?How to manage atrial fibrillation: an update on recent clinical trials.

Find a Location

Who is running the clinical trial?

Farapulse, Inc.Lead Sponsor
9 Previous Clinical Trials
451 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
451 Patients Enrolled for Atrial Fibrillation
Vivek Reddy, MDPrincipal InvestigatorMt. Sinai
33 Previous Clinical Trials
10,396 Total Patients Enrolled
18 Trials studying Atrial Fibrillation
4,962 Patients Enrolled for Atrial Fibrillation

Media Library

FARAPULSE Pulsed Field Ablation System (Pulsed Field Ablation System) Clinical Trial Eligibility Overview. Trial Name: NCT04612244 — N/A
Atrial Fibrillation Research Study Groups: FARAPULSE Pulsed Field Ablation System, Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
Atrial Fibrillation Clinical Trial 2023: FARAPULSE Pulsed Field Ablation System Highlights & Side Effects. Trial Name: NCT04612244 — N/A
FARAPULSE Pulsed Field Ablation System (Pulsed Field Ablation System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04612244 — N/A
~208 spots leftby Jul 2025