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

NCT07281521 | Recruiting FDA Device

• 1 other identifier: 25-6647
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

Brief Summary

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).

Conditions

Persistant Atrial Fibrillation

Keywords

ablation; pulsed field ablation; atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Rate of Primary Serious Adverse Events

  The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * Atrio-esophageal fistula (assessed at ≥60 days) * Cardiac perforation, tamponade, or pericardial effusion * Cerebrovascular accident (CVA)/stroke * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in persistent diaphragmatic paralysis (assessed at ≥60 days) * Pulmonary vein stenosis (assessed at ≥60 days) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury/gastroparesis

  7 days (unless otherwise specified)

• Primary Effectiveness Endpoint - Acute Procedure Success

  Percentage of treated pulmonary veins with documented PVI at the end of the index procedure using the study device only. Acute PVI will be assessed by the confirmation of entrance and/or exit block. • Inability to isolate a targeted pulmonary vein with the study device and requiring use of a non-study ablation device to complete PVI will count as an acute procedure failure.

  During procedure

Secondary Outcomes (3)

• Chronic PVI Durability

  60 days post-procedure

• Acute Success of Additional Atrial Lesion Sets

  During procedure

• 12-Month Freedom from Atrial Arrhythmia

  12 months post-procedure

Study Arms (1)

Pulsed Field Ablation Treatment

EXPERIMENTAL

The treatment arm will undergo catheter ablation for persistent atrial fibrillation with the PFA system with a Large-Area Focal Catheter

Device: pulsed field ablation

Interventions

pulsed field ablation DEVICE

pulsed field ablation with a large-area focal catheter

Pulsed Field Ablation Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:
• Paroxysmal AF (Phase A participants)
• 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
• Persistent AF (Phase A, B, and C participants)
• 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
• Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR
• History of ≥2 direct current cardioversion (DCCV) performed within 12 months prior to enrollment
• Failure or intolerance of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic PerAF or intolerable side effects due to the AAD
• Age 18 through 75 years-old on the day of enrollment
• Patient is indicated for an ablation procedure according to society guidelines or study site practice
• Patient is willing and able to give informed consent and is willing, able, and committed to participate in baseline and follow-up evaluations for the full duration of the study

You may not qualify if:

• 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
• Presence of any permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator (with or without biventricular pacing function) that cannot be programmed, per the manufacturer's recommendations, during the ablation procedure
• Patient cannot be removed from AADs for reasons other than AF, which includes participants with Wolff-Parkinson-White (WPW) Syndrome and participants with a history of ventricular tachycardia (VT)
• Presence of any IVC filters
• Presence of an interatrial baffle or patch
• Presence of any pulmonary vein stents
• Pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Atrial or ventricular septal defect closure
• Atrial myxoma
• Presence of any mechanical or biologic prosthetic heart valve
• Hemodynamically significant valvular disease as determined by the Investigator

Sponsors & Collaborators

• CardioFocus: lead

Study Sites (3)

KBC Split

Split, Croatia

RECRUITING

St. Anne's University Hospital

Brno, Czechia

NOT YET RECRUITING

Homolka

Prague, Czechia

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tine Wouters

CONTACT

+32 498 774371; twouters@cardiofocus.com

Vikramaditya Mediratta

CONTACT

714-717-2376; vmediratta@cardiofocus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 15, 2025
• Study Start: February 27, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); CR (1)