Actively Recruiting
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-02-13
150
Participants Needed
2
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic paroxysmal or persistent atrial fibrillation documented by a physician's note and 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 to less than 75 years
- Able and willing to give informed consent
- Able, willing, and has means to comply with pre-procedure, post-procedure, and follow-up testing requirements
You will not qualify if you...
- Continuous atrial fibrillation lasting more than 12 months (long-standing persistent AF)
- AF caused by electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible/non-cardiac causes
- Previous left atrial catheter or surgical ablation
- Valvular cardiac surgery or percutaneous procedure, including prosthetic valve presence
- Any carotid stenting or endarterectomy
- Cardiac procedure or percutaneous coronary intervention within 90 days before the initial procedure
- Coronary artery bypass graft surgery within 6 months prior to the ablation
- Awaiting cardiac transplantation or other cardiac surgery within 12 months following ablation
- Presence of any implantable cardiac defibrillator
- Stroke or transient ischemic attack within the past 6 months
- Left atrial thrombus on imaging
- History of blood clotting or bleeding disorders
- Conditions contraindicating chronic anticoagulation
- Myocardial infarction within 3 months prior to the procedure
- Body mass index over 40 kg/m2
- Left atrial diameter over 50 mm for paroxysmal AF or over 55 mm for persistent AF
- Diagnosed atrial myxoma
- Left ventricular ejection fraction less than 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
- Primary pulmonary hypertension
- Significant restrictive or obstructive pulmonary or chronic respiratory disease
- Renal failure requiring dialysis
- Acute illness, active systemic infection, or sepsis
- Significant congenital anomaly or medical problem affecting study participation
- Pregnant or breastfeeding women or women not using reliable birth control
- Participation in another clinical trial without sponsor approval
- Presence of intramural thrombus, tumor, or other vascular abnormalities
- Known drug or alcohol dependency
- Life expectancy less than 12 months
- Vulnerable subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Homolka Hospital
Prague, Czechia
Actively Recruiting
2
Institute Klinicke a Experimentalni Mediciny
Prague, Czechia
Actively Recruiting
Research Team
S
Sandra Jacobs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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