RecruitingNot ApplicableNCT05115214

Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

150 participants

Start Date

Oct 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating the safety and effectiveness of a new catheter ablation system called the Affera SpherePVI — a tool that uses heat or cold energy to create scar tissue around the pulmonary veins in the heart to stop the abnormal electrical signals that cause atrial fibrillation (AFib). AFib is an irregular heart rhythm that can cause palpitations, fatigue, and stroke risk. **You may be eligible if...** - You have symptomatic atrial fibrillation (paroxysmal or short-term persistent) confirmed by at least two ECG-documented episodes in the past year - You have tried and failed at least one anti-arrhythmic drug (or could not tolerate it) - You are 18 to 74 years old and are considered a suitable candidate for catheter ablation **You may NOT be eligible if...** - Your AFib has been continuous for more than 12 months - Your AFib is caused by a reversible problem like thyroid disease or alcohol - You have had a prior ablation procedure on the left side of the heart - You have had recent heart valve surgery, a mechanical heart valve, or carotid stenting - You have active blood clots in the heart or cannot take blood thinners - You are pregnant or have other serious medical conditions 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

DEVICESpherePVI™ Catheter

Affera SpherePVI™ Multi-Ablation System


Locations(2)

Homolka Hospital

Prague, Czechia

Institute Klinicke a Experimentalni Mediciny

Prague, Czechia

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NCT05115214


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