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

NCT06828939 | Recruiting FDA Device

• 1 other identifier: 25-6073
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (Paroxysmal)

Keywords

ablation; pulsed field ablation

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint - Acute Procedure Success

  Pulmonary vein isolation at the end of the index procedure

  During procedure

• 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: * 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

  7 days (unless otherwise specified)

Secondary Outcomes (2)

• Secondary Effectiveness Endpoint - Chronic Durability

  90 days

• Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia

  12 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System

Device: pulsed field ablation

Interventions

pulsed field ablation DEVICE

Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• overall good health as established by multiple criteria

Sponsors & Collaborators

• CardioFocus: lead

Study Sites (1)

Na Homolce Hospital

Prague, Czech Republic, Czechia

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

Vikramaditya Mediratta, MS

CONTACT

714-717-2376; vmediratta@cardiofocus.com

Lisa Hausmann, MPH

CONTACT

508-658-7253; lhausmann@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

Model Details: OptiShot PFA Balloon System

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 17, 2025
• Study Start: December 12, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)