Using the Affera SpherePVI™ System to Treat Atrial Fibrillation

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

This study is testing a new device to see if it can safely help people with paroxysmal atrial fibrillation feel better by using a procedure called catheter ablation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Medtronic Cardiac Ablation Solutions (Industry-sponsored)
• Locations: 2 sites (Prague and 1 other locations)
• Trial ID: NCT05115214 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Affera SpherePVI™ Multi-Ablation System in treating patients with paroxysmal atrial fibrillation. It is a prospective, single-arm, multi-center approach that involves catheter ablation to address the condition. Participants will be monitored for performance outcomes and safety throughout the process. The study aims to provide insights into the system's ability to manage this type of arrhythmia effectively.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with symptomatic paroxysmal atrial fibrillation who have not responded to at least one anti-arrhythmic drug.

Not a fit: Patients with continuous atrial fibrillation lasting more than 7 days or those with AF due to reversible causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from paroxysmal atrial fibrillation.

How similar studies have performed: Other studies have shown promise in using catheter ablation for atrial fibrillation, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.
3. Suitable candidate for catheter ablation.
4. Age ≥ 18 and \< 75 years.
5. Able and willing to give informed consent.
6. Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements.

Exclusion Criteria:

Subjects will not be eligible for the study if any of the following criteria are met:

1. Continuous AF lasting more than 12 months (long-standing persistent AF).
2. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.
3. Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure).
4. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
5. Any carotid stenting or endarterectomy.
6. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.
7. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.
8. Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure.
9. Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).
10. Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).
11. Documented left atrial thrombus on imaging.
12. History of blood clotting or bleeding abnormalities.
13. Any condition contraindicating chronic anticoagulation.
14. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
15. Body mass index \>40 kg/m2.
16. Left atrial diameter (anteroposterior) \>50 mm for paroxysmal AF and \>55mm for persistent AF.
17. Diagnosed atrial myxoma.
18. Left ventricular ejection fraction (EF) \< 40%.
19. Uncontrolled heart failure or NYHA Class III or IV heart failure.
20. Rheumatic heart disease.
21. Hypertrophic cardiomyopathy.
22. Unstable angina.
23. Moderate to severe mitral valve stenosis.
24. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
25. Primary pulmonary hypertension.
26. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
27. Renal failure requiring dialysis.
28. Acute illness, active systemic infection, or sepsis.
29. 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.
30. 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.
31. 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.
32. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
33. Known drug or alcohol dependency.
34. Life expectancy less than 12 months.
35. Vulnerable subject.

Where this trial is running

Prague and 1 other locations

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

Study contacts

• Study coordinator: Sandra Jacobs

Conditions Atrial Fibrillation