Pulse Field Ablation for Atrial Fibrillation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrial Fibrillation
Pulse Field Ablation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 3 - 12 months

12 months
QOL Improvement
3 - 12 months
Freedom of arrhythmia recurrence
7 days
Incidence of early onset Primary Adverse Events

Trial Safety

Trial Design

1 Treatment Group

Treatment Group
1 of 1

Experimental Treatment

362 Total Participants · 1 Treatment Group

Primary Treatment: Pulse Field Ablation · No Placebo Group · N/A

Treatment Group
Device
Experimental Group · 1 Intervention: Pulse Field Ablation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 - 12 months

Who is running the clinical trial?

Biosense Webster, Inc.Lead Sponsor
111 Previous Clinical Trials
30,356 Total Patients Enrolled
73 Trials studying Atrial Fibrillation
21,212 Patients Enrolled for Atrial Fibrillation
Biosense Webster Inc. Clinical TrialStudy DirectorBiosense Webster, Inc.

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least two symptomatic episodes of atrial fibrillation within the last six months from enrollment.
You have at least one episode of atrial fibrillation within the past 12 months.
You have a history of taking an antiarrhythmic drug.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Illinois50.0%
California50.0%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
Memorial Health University Medical Center50.0%
Texas Cardiac Arrhythmia Research Foundation50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%