← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ADVENT Trial 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.

ADVENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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?
Select...
I have episodes of irregular heartbeat.
Select...
My heart rhythm medication did not work or caused side effects.
Select...
I am between 18 and 75 years old.
Select...
My atrial fibrillation symptoms persist despite trying medications.
Select...
I am between 18 and 75 years old.

ADVENT Trial 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

ADVENT 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

Find a Location

Who is running the clinical trial?

Farapulse, Inc.Lead Sponsor
9 Previous Clinical Trials
431 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
431 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who are the accepted candidates for participation in this experiment?

"Potential candidates for this medical trial should be between 18 and 75 years old, suffer from atrial fibrillation, and there are space for 900 individuals in total."

Answered by AI

Does this clinical trial accept participants in excess of thirty years old?

"This clinical trial seeks adults aged 18 years and over, up to the age of 75."

Answered by AI

Is this research still accepting participants?

"Unfortunately, based on the clinicaltrials.gov data this study is no longer enrolling patients; though it was initially posted back in March 2021 and last updated in October 2022. Fortunately, there are still 477 other trials actively searching for volunteers at this time."

Answered by AI

What is the geographic scope of this investigation?

"At the present, this research project is open to enrolment at 36 different sites. These medical centres are scattered across Redwood City, Sacramento, and New Orleans as well other nearby cities. Participants should consider selecting a site near them for minimal travelling demands if they decide to join in on the study."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
California Pacific Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
2021. "The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04612244.
~220 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top