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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05115214

Run by

Medtronic Cardiac Ablation Solutions

People needed

150

Starts

2021-10-19

Expected to finish

2027-10-15

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic paroxysmal or persistent atrial fibrillation (PAF) documented by:
• A physician's note indicating recurrent AF
• At least two electrocardiographically documented AF episodes within 12 months prior to enrollment
• Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.
• Suitable candidate for catheter ablation.
• Age ≥ 18 and < 75 years.
• Able and willing to give informed consent.
• Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements.

You may not qualify if…

• Subjects will not be eligible for the study if any of the following criteria are met:
• Continuous AF lasting more than 12 months (long-standing persistent AF).
• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.
• Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure).
• Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• Any carotid stenting or endarterectomy.
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.
• Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure.
• Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).
• Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).
• Documented left atrial thrombus on imaging.
• History of blood clotting or bleeding abnormalities.
• Any condition contraindicating chronic anticoagulation.
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• Body mass index >40 kg/m2.
• Left atrial diameter (anteroposterior) >50 mm for paroxysmal AF and >55mm for persistent AF.
• Diagnosed atrial myxoma.
• Left ventricular ejection fraction (EF) < 40%.
• Uncontrolled heart failure or NYHA Class III or IV heart failure.
• Rheumatic heart disease.
• Hypertrophic cardiomyopathy.
• Unstable angina.
• Moderate to severe mitral valve stenosis.
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).

Where it is running

• Homolka Hospital — Prague, Czechia (enrolling)
• Institute Klinicke a Experimentalni Mediciny — Prague, Czechia (enrolling)

Full record on ClinicalTrials.gov

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