RecruitingNot ApplicableNCT07281521

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

Safety & Effectiveness of the CardioWave Pulsed Field Ablation System With the QuickShot Nav Large-Area Focal Catheter for Ablation of Persistent Atrial Fibrillation


Sponsor

CardioFocus

Enrollment

200 participants

Start Date

Feb 27, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new catheter ablation technique (using electrical pulses rather than heat to destroy abnormal heart tissue) for treating persistent or paroxysmal atrial fibrillation — a condition where the heart beats irregularly. **You may be eligible if...** - You have been diagnosed with paroxysmal atrial fibrillation (episodes that start and stop on their own, lasting less than 7 days) or persistent atrial fibrillation (lasting longer) - Your irregular heartbeat has been documented on an ECG, Holter monitor, or similar device within the past 12 months - A doctor has confirmed your symptoms are caused by atrial fibrillation **You may NOT be eligible if...** - You have certain types of structural heart disease (e.g., severe valve problems or dilated cardiomyopathy) - You have had a previous catheter ablation for any heart rhythm problem - You have other heart rhythm problems that also require ablation at the same time - You have uncontrolled high blood pressure or other conditions that may make ablation unsafe 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 with a large-area focal catheter


Locations(3)

KBC Split

Split, Croatia

St. Anne's University Hospital

Brno, Czechia

Homolka

Prague, Czechia

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NCT07281521


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