Pulmonary Vein Isolation with the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation (Paroxysmal)

• Registration Number: NCT06828939
• Lead Sponsor: CardioFocus

Brief Summary

This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Detailed Description

This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Study Timeline

• Study Start: 2024-12-12
• Status Verified: 2025-01
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-07-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Recurrent symptomatic PAF with at least one documented episode
• Failure or intolerance of at least one AAD
• Age 18-75 years
• Patient is indicated for an ablation procedure according to society guidelines or study site practice
• Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study

Exclusion Criteria

• overall good health as established by multiple criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint - Acute Procedure Success	During procedure	Pulmonary vein isolation at the end of the index procedure
Primary Safety Endpoint - Rate of Primary Serious Adverse Events	7 days (unless otherwise specified)	The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * AE fistula (assessed at \>=60 days); * Cardiac perforation, tamponade, or pericardial effusion; * Complete heart block; * Death; * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion; * MI; * Pericarditis; * PNI resulting in persistent diaphragmatic paralysis (assessed at \<=60 days); * PV stenosis (assessed at \<=60 days); * Stroke/CVA; * Thromboembolism; * TIA; * Vagal nerve injury/gastroparesis

Secondary Outcome Measures

Name	Time	Method
Secondary Effectiveness Endpoint - Chronic Durability	90 days	Percentage of treated PVs with documented PVI at the remapping procedure
Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia	12 months	Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of \> 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor

Trial Locations

Locations (1)

Na Homolce Hospital; 🇨🇿 Prague, Czech Republic