Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCardioFocus

About this trial

The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).

Eligibility criteria

Qualifiers

Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND

At least one documented episode of AF captured continuously on 12-lead ECG, or for at least 30 seconds on transtelephonic monitor (TTM), Holter monitor, telemetry strip, or similar within 12 months prior to enrollment

Physician's note indicating symptoms consistent with recurrent symptomatic PerAF AND

Any 24-hour ECG recording of continuous AF within 12 months prior to enrollment OR

Disqualifiers

Long-standing persistent AF (continuous AF sustained > 1 year)

AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes

Prior cardiac ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion, or valvular cardiac procedure)

Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during study participation

Trial design

Treatments tested in this trial

  • pulsed field ablation

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators