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ClinicalTrials.gov ID

NCT07789925

Lead Sponsor

Medtronic Cardiac Ablation SolutionsINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

180Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Sep 2, 2026Estimated

Primary Completion Date

Apr 2028Estimated

Completion Date

Apr 2028Estimated

Official Title

Treatment of Paroxysmal Atrial Fibrillation With the Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System in China

Brief Summary

The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF.

The main questions it aims to answer are:

Is the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System safe for treating PAF? Does the treatment help keep patients free from atrial fibrillation and other abnormal heart rhythms during the 12 months after the procedure?

Participants will:

Have their heart rhythm assessed before and after the ablation procedure. Have PAF treated using the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System.

Have follow-up visits at 3, 6, and 12 months after the procedure.

• Paroxysmal Atrial Fibrillation (PAF)

• Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Failure of, intolerance to, or contraindication to at least one Class I-IV AAD for the treatment of PAF, as evidenced by recurrent symptomatic AF. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:

   1. a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
   2. at least 1 electrocardiographically documented episode within 12 months prior to enrollment

2. Adults who are ≥18 and ≤80 years of age on the day of enrollment.

3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

Exclusion Criteria:

1. Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days
2. AF that required three (3) or more distinct cardioversions in the preceding 12 months.
3. LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)
4. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
5. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
6. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
7. Presence of a permanent pacemaker, biventricular pacemaker, , or any type of implantable cardiac defibrillator (with or without biventricular pacing function), , or presence of a loop recorder or insertable cardiac monitor (ICM) that has not reached manufacturer-defined end of service (or equivalent end-of-life state)
8. Presence of any pulmonary vein stents
9. Known pre-existing pulmonary vein stenosis
10. Pre-existing hemidiaphragmatic paralysis
11. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
12. Moderate to severe aortic or mitral valve stenosis
13. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
14. Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
15. Unstable angina
16. NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
17. Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen
18. Rheumatic heart disease
19. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
20. Contraindication to or unwillingness to use systemic anticoagulation
21. Documented left atrial thrombus on imaging
22. Active systemic infection or sepsis
23. Hypertrophic cardiomyopathy
24. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
26. Carotid stenting or endarterectomy
27. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
28. 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
29. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
30. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
31. Known allergies or hypersensitivities to adhesives
32. Body mass index > 40 kg/m2
33. Atrial myxoma
34. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
35. Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
36. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
37. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
38. Known drug or alcohol dependency
39. 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.
40. Treatment with Amiodarone within the 3 months prior to enrollment
41. Amyloid heart disease (cardiac amyloidosis)

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Medtronic Cardiac Ablation SolutionsINDUSTRY

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