RecruitingNot ApplicableNCT06828939

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

Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation


Sponsor

CardioFocus

Enrollment

75 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new balloon-based procedure for treating paroxysmal atrial fibrillation (AF) — a condition where the heart beats irregularly in sudden episodes. The procedure uses a technique called pulsed field ablation (PFA), which uses energy pulses delivered through a balloon to disconnect the electrical triggers in the heart that cause AF. **You may be eligible if...** - You have recurring symptomatic atrial fibrillation with at least one documented episode - At least one anti-arrhythmia medication has not worked or has caused side effects - You are between 18 and 75 years old - Your doctor has recommended an ablation procedure for your AF - You are willing and able to participate in follow-up visits **You may NOT be eligible if...** - You have other serious health conditions that would make the procedure unsafe - You have had prior heart ablation procedures (depending on study specifics) - You have structural heart problems that would interfere with the balloon procedure - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEpulsed field ablation

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


Locations(1)

Na Homolce Hospital

Prague, Czech Republic, Czechia

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NCT06828939


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