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Pulse Field Ablation

Pulse Field Ablation for Atrial Fibrillation(AdmIRE Trial)

N/A
Waitlist Available
Research Sponsored by Biosense Webster, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation
Failed at least one Class I or Class III antiarrhythmic drug
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3 - 12 months
Awards & highlights
No Placebo-Only Group

AdmIRE Trial Summary

This trial is testing a new device to treat atrial fibrillation. The device is safe and effective for 12 months.

AdmIRE Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have been diagnosed with symptomatic paroxysmal atrial fibrillation.
Select...
You have tried at least one type of medication for heart rhythm problems, but it didn't work.
Select...
You have experienced at least two episodes of symptomatic atrial fibrillation in the past six months.
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You have had a documented episode of atrial fibrillation within the past year.

AdmIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 - 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 - 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
Freedom of arrhythmia recurrence
Incidence of early onset Primary Adverse Events
Secondary outcome measures
QOL Improvement

Awards & Highlights

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

AdmIRE Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Find a Location

Who is running the clinical trial?

Biosense Webster, Inc.Lead Sponsor
118 Previous Clinical Trials
36,847 Total Patients Enrolled
77 Trials studying Atrial Fibrillation
27,462 Patients Enrolled for Atrial Fibrillation
Biosense Webster Inc. Clinical TrialStudy DirectorBiosense Webster, Inc.

Media Library

VARIPULSE™ Catheter (Pulse Field Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT05293639 — N/A
Atrial Fibrillation Research Study Groups: Treatment Group
Atrial Fibrillation Clinical Trial 2023: VARIPULSE™ Catheter Highlights & Side Effects. Trial Name: NCT05293639 — N/A
VARIPULSE™ Catheter (Pulse Field Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05293639 — N/A
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT05293639 — N/A

Frequently Asked Questions

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

Are there a considerable number of sites in the US running this clinical research?

"This trial is recruiting patients from 34 different sites, such as the Albert Einstein College of Medicine in Bronx, Piedmont Healthcare in Atlanta, and Virginia Commonwealth University in Richmond."

Answered by AI

Is the minimum age limit for this trial set at twenty years or younger?

"This medical trial has a lower age limit of 18 years old, and an upper bound of 75."

Answered by AI

What criteria must a participant meet to be eligible for this trial?

"This clinical study seeks 362 participants who are 18-75 and suffering from symptomatic paroxysmal atrial fibrillation. Eligibility criteria include two episodes of AF in the last six months, one episode documented on ECG within 12 months, and failure to respond to Class I or III antiarrhythmic drugs."

Answered by AI

Does this trial still have vacancies for prospective participants?

"Based on information provided by clinicaltrials.gov, this trial is not currently recruiting participants and has been inactive since November 28th 2022. Despite this fact, there remain 476 other studies actively searching for eligible candidates."

Answered by AI

Who else is applying?

What state do they live in?
California
Illinois
Alabama
How old are they?
65+
18 - 65
What site did they apply to?
Memorial Health University Medical Center
Texas Cardiac Arrhythmia Research Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Currently taking medication that is not working well to control episodes of arrhythmias.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What is the screening criteria?
PatientReceived 2+ prior treatments
~34 spots leftby Jan 2024