This study is in progress, not accepting new patients

The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation

a study on Atrial Fibrillation Heart Conditions

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Edward Gerstenfeld
Headshot of Edward Gerstenfeld
Edward Gerstenfeld

Description

Summary

This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.

Official Title

A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal Atrial Fibrillation, Atrial Fibrillation, FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation, Force Sensing Radiofrequency Ablation and Cryoballoon Ablation

Eligibility

You can join if…

Open to people ages 18-75

Patients are required to meet all the following inclusion criteria to participate in this study:

- Age 18-75 - Paroxysmal atrial fibrillation - Anti-arrhythmic drug failed for efficacy or intolerance

You CAN'T join if...

Patients will be excluded from participating in this study if they meet any one of the following exclusion criteria:

- Atrial diameter greater than 5.5 cm - Prior atrial ablation or surgery - Left ventricular ejection fraction < 40% - Implantable cardiac devices - Heart surgery or stroke within 6 months of enrollment - Renal impairment - Body mass index greater than 40

Locations

  • UCSF (UCSF)
    San Francisco California 94143 United States
  • California Pacific Medical Center
    San Francisco California 94109 United States

Lead Scientist at UCSF

  • Edward Gerstenfeld
    Dr Gerstenfeld is the Melvin Scheinman Endowed Professor of Medicine and Chief of the Section of Cardiac Electrophysiology at UCSF.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Farapulse, Inc.
ID
NCT04612244
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated