Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
NCT ID: NCT05115214
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2021-10-19
2027-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
NCT05144503
Ablation of the Pulmonary Veins for Paroxysmal Afib
NCT00744874
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
NCT06703489
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
NCT02703454
Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance
NCT02497248
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SpherePVI™ Catheter
Subjects treated with the SpherePVI™ Catheter
SpherePVI™ Catheter
Affera SpherePVI™ Multi-Ablation System
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SpherePVI™ Catheter
Affera SpherePVI™ Multi-Ablation System
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A physician's note indicating recurrent, self-terminating 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
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 \>50 mm (anteroposterior).
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Homolka Hospital
Prague, , Czechia
Institute Klinicke a Experimentalni Mediciny
Prague, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Petr Neužil, MD. PhD
Role: primary
Petr Peichl, MD. PhD.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Reddy VY, Peichl P, Kautzner J, Anter E, Metzner A, Koruth J, Jais P, Rackauskas G, Petru J, Funasako M, Marinskis G, Turagam M, Aidietis A, Selma JM, Nejedlo V, Kueffer F, Tarakji KG, Natale A, Neuzil P. One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation. Heart Rhythm. 2025 Oct;22(10):2551-2561. doi: 10.1016/j.hrthm.2025.04.031. Epub 2025 Apr 26.
Reddy VY, Anter E, Peichl P, Rackauskas G, Petru J, Funasako M, Koruth JS, Marinskis G, Turagam M, Aidietis A, Kautzner J, Natale A, Neuzil P. First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation. Europace. 2024 Mar 30;26(4):euae090. doi: 10.1093/europace/euae090.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP-00013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.