Tests a heart catheter device for paroxysmal atrial fibrillation
Tests the SpherePVI catheter to treat irregular heartbeats in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
Key facts
- Where
- Prague, CzechiaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05115214, who can take part
Where in Czechia
- Homolka HospitalPrague, CzechiaTaking people
- Institute Klinicke a Experimentalni MedicinyPrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic Cardiac Ablation Solutions
- Trial code
- NCT05115214
- Record updated
- 15 September 2026
- Original description
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.Read full original descriptionShow less
A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
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.
Inclusion: 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.
Exclusion: Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure); 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; Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure; Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor; Known drug or alcohol dependency; AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause; Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve); 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); History of blood clotting or bleeding abnormalities; Any condition contraindicating chronic anticoagulation; Uncontrolled heart failure or NYHA Class III or IV heart failure; Rheumatic heart disease; Unstable angina; Primary pulmonary hypertension; Significant restrictive or obstructive pulmonary disease or chronic respiratory condition; Renal failure requiring dialysis; Acute illness, active systemic infection, or sepsis; Left ventricular ejection fraction (EF) < 40%; 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); Any carotid stenting or endarterectomy; Documented left atrial thrombus on imaging; Body mass index >40 kg/m2; Left atrial diameter (anteroposterior) >50 mm for paroxysmal AF and >55mm for persistent AF; Diagnosed atrial myxoma; Hypertrophic cardiomyopathy; 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); Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results; Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence; Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation; Life expectancy less than 12 months; Vulnerable subject.