Pulsed Field Ablation for Atrial Fibrillation

Phase-Based Progress Estimates
University of California, San Francisco-Hospital, San Francisco, CAAtrial FibrillationFARAPULSE Ablation System - Device
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new device to treat atrial fibrillation, a common heart rhythm disorder.

Eligible Conditions
  • Atrial Fibrillation

Treatment Effectiveness

Study Objectives

10 Primary · 0 Secondary · Reporting Duration: 360 Days

0 Days
Primary Effectiveness Endpoint - Acute Procedural Success
Rate of Persistent AF Acute Procedural Success
30 Days
Primary Safety Endpoint at 30 days Post Procedure
Rate of Safety Events at 30 days Post Procedure
360 Days
Primary Effectiveness Endpoint - Chronic Success
Primary Safety Endpoint at 12 Months Post Procedure
Rate of Persistent AF Chronic Success
Rate of Safety Events at 12 Months Post Procedure
7 Days
Primary Safety Endpoint at 7 days Post Procedure
Rate of Safety Events at 7 days Post Procedure

Trial Safety

Trial Design

1 Treatment Group

Pulsed Field Ablation
1 of 1

Experimental Treatment

417 Total Participants · 1 Treatment Group

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

Pulsed Field Ablation
Experimental Group · 1 Intervention: FARAPULSE Ablation System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 360 days

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
679 Previous Clinical Trials
919,821 Total Patients Enrolled
57 Trials studying Atrial Fibrillation
18,928 Patients Enrolled for Atrial Fibrillation
Vivek ReddyPrincipal InvestigatorMOUNT SINAI HOSPITAL

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.