Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Mapping and Ablation

• Registration Number: NCT05120193
• Lead Sponsor: Medtronic Cardiac Ablation Solutions

Brief Summary

This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-15
• Study Start: 2021-12-14
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Results First Submitted: 2025-01-09
• Results First Submitted QC: 2025-01-09
• Results First Posted: 2025-02-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

1. Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF.
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

1. Continuous AF lasting for 12 months or longer.
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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sphere-9 Catheter	Mapping and Ablation	Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
THERMOCOOL SMARTTOUCH SF	Mapping and Ablation	THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System

Primary Outcome Measures

Name	Time	Method
Percent of Subjects With a Primary Adverse Event	180 Days	The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: Within 7 days: * Death; * Myocardial infarction; * Phrenic nerve paralysis; * Transient ischemic attack (TIA); * Stroke/cerebrovascular accident (CVA); * Thromboembolism; * Major vascular access complications / bleeding; * Heart block; * Gastroparesis; * Severe pericarditis; * Hospitalization due to cardiovascular or pulmonary AE; Within 30 days: • Cardiac tamponade / perforation; Within 90 days: • Atrio-esophageal fistula; Within 180 days: • Pulmonary vein stenosis
Percent of Subjects Free From Primary Effectiveness Failure	12 months	The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90-day blanking period. The following are considered primary effectiveness endpoint failures: * Inability to isolate all targeted pulmonary veins during the index procedure.; * Ablation using devices other than the assigned study device for any left atrial ablation during the index procedure.; * Any repeat ablation, surgical ablation, or arrhythmia surgery for treatment of recurrent AF/AT/AFL after the index procedure.; * Documented AF/AT/AFL recurrence after the 90-day blanking period.; * Class I or III AAD dose increase from the historic maximum ineffective dose (prior to the index procedure) or initiation of a new Class I or III AAD for treatment of AF/AT/AFL after the 90-day blanking period.; * DC cardioversion for AF/AT/AFL after the 90-day blanking period.

Secondary Outcome Measures

Name	Time	Method
Energy Application Time	Day 0	Total energy application time during the index ablation procedure
Treatment Time	Day 0	Time from start to end of energy delivery
Procedure Time	Day 0	Time from start to end of venous access

Trial Locations

Locations (23)

Arrhythmia Research Group; 🇺🇸 Jonesboro, Arkansas, United States

The OhioHealth Research Institute; 🇺🇸 Columbus, Ohio, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Shamir Medical Center; 🇮🇱 Zrifin, Israel

Nemocnice Ceske Budejovice; 🇨🇿 České Budějovice, Czechia

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Institut Klinicke a Experimentani Mediciny; 🇨🇿 Praha 4, Czechia

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

Nemocnice Na Homolce; 🇨🇿 Praha 5, Czechia

Doylestown Hospital; 🇺🇸 Doylestown, Pennsylvania, United States

University of Pittsburgh Medical Center Pinnacle Health; 🇺🇸 Wormleysburg, Pennsylvania, United States

Arrhythmia Institute at Grandview; 🇺🇸 Birmingham, Alabama, United States

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States

Naples Heart Institute; 🇺🇸 Naples, Florida, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Pacific Heart Institute; 🇺🇸 Santa Monica, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Northwell Health; 🇺🇸 New York, New York, United States

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States