RecruitingNot ApplicableNCT05144503

Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation

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


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

100 participants

Start Date

Jul 22, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of a new catheter device called SpherePVI for treating atrial fibrillation (an irregular heart rhythm) using a procedure called catheter ablation — where heat or cold energy is used to disrupt the abnormal electrical signals in the heart. **You may be eligible if...** - You are between 18 and 74 years old - You have symptomatic atrial fibrillation (AF) confirmed on at least two ECG recordings in the past year - At least one heart rhythm medication has not worked or you couldn't tolerate it - You are a suitable candidate for catheter ablation **You may NOT be eligible if...** - Your AF has been continuous for more than 12 months - You have had a prior ablation procedure or heart surgery involving the left side of the heart - You have had a stroke or mini-stroke (TIA) in the past 6 months - You have a pacemaker or defibrillator implant - You have severe heart failure, a very large left atrium, or a heart ejection fraction below 40% - You have had a heart attack in the past 3 months - You are pregnant or breastfeeding 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

SpherePVI™ Catheter with the Affera Mapping and Ablation System


Locations(1)

Vilnius University Hospital

Vilnius, Lithuania

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NCT05144503


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