Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
NCT ID: NCT05120193
Last Updated: 2025-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
477 participants
INTERVENTIONAL
2021-12-14
2024-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sphere-9 Catheter
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation
Minimally invasive catheter mapping and ablation procedure
THERMOCOOL SMARTTOUCH SF
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation
Minimally invasive catheter mapping and ablation procedure
Interventions
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Mapping and Ablation
Minimally invasive catheter mapping and ablation procedure
Eligibility Criteria
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Inclusion Criteria
2. Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD).
3. Suitable candidate for catheter ablation.
4. Adults aged 18 - 80 years.
5. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
6. Willing and able to provide informed consent.
Exclusion Criteria
2. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
3. Previous left atrial ablation or surgical procedure (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 the 90 days prior to the initial procedure.
7. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
8. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
9. Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
10. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
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 \>55 mm (anterioposterior).
17. Diagnosed atrial myxoma.
18. Left ventricular ejection fraction (EF) \< 35%.
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. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
29. Acute illness, active systemic infection, or sepsis.
30. Contraindication to both computed tomography and magnetic resonance angiography.
31. 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 study results.
32. 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.
33. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
34. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
35. Known drug or alcohol dependency.
36. Life expectancy less than 12 months.
37. Vulnerable subject (such as a prisoner or handicapped or mentally disabled person).
18 Years
80 Years
ALL
No
Sponsors
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Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
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Locations
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Arrhythmia Institute at Grandview
Birmingham, Alabama, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Pacific Heart Institute
Santa Monica, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Naples Heart Institute
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Maimonides Medical Center
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Northwell Health
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The OhioHealth Research Institute
Columbus, Ohio, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
University of Pittsburgh Medical Center Pinnacle Health
Wormleysburg, Pennsylvania, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Nemocnice Ceske Budejovice
České Budějovice, , Czechia
Institut Klinicke a Experimentani Mediciny
Prague, , Czechia
Nemocnice Na Homolce
Prague, , Czechia
Shamir Medical Center
Zrifin, , Israel
Countries
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References
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Matsumoto K, van Bragt KA, Kueffer FJ, Mburu W, Tarakji KG. Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation. J Interv Card Electrophysiol. 2025 Sep 10. doi: 10.1007/s10840-025-02124-6. Online ahead of print.
Kiehl EL, Mountantonakis SE, Mansour MC, Nair DG, Sharma D, Taigen TL, Neuzil P, Kautzner J, Osorio J, Natale A, Hummel JD, Amin AK, Siddiqui UR, Bulava A, Doshi SK, Patel CP, Greenberg YJ, Tung RH, Harlev D, Hultz P, Rosen S, van Bragt KA, Tarakji KG, Reddy VY, Anter E; SPHERE Per-AF Investigators. Operator learning curve with a novel dual-energy lattice-tip ablation system. Heart Rhythm. 2025 Feb 6:S1547-5271(25)00120-1. doi: 10.1016/j.hrthm.2025.02.006. Online ahead of print.
Anter E, Mansour M, Nair DG, Sharma D, Taigen TL, Neuzil P, Kiehl EL, Kautzner J, Osorio J, Mountantonakis S, Natale A, Hummel JD, Amin AK, Siddiqui UR, Harlev D, Hultz P, Liu S, Onal B, Tarakji KG, Reddy VY; SPHERE PER-AF Investigators. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. 2024 Aug;30(8):2303-2310. doi: 10.1038/s41591-024-03022-6. Epub 2024 May 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP-00009
Identifier Type: -
Identifier Source: org_study_id
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