Paroxysmal Atrial Fibrillation (PAF)
Conditions
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.
Interventions
DEVICECatheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System
Pulsed field catheter ablation for pulmonary vain isolation.
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation | Through 6 months post-ablation | The proportion of participants who are free from device- and/or procedure-related serious adverse events through 6 months after the ablation procedure. |
| Primary effectiveness endpoint: Treatment Success at 12 Months Post-Ablation | 12 months post-ablation | The proportion of participants achieving treatment success (freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data) at 12 months after the ablation procedure and excluding a 90-day blanking period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires score from baseline through 12 months after the index ablation procedure | Baseline through 12 months after the index ablation | Change in AFEQT score from baseline to 12 months after the index ablation procedure. The AFEQT questionnaire assesses the impact of atrial fibrillation on a participant's quality of life. The overall score ranges from 0 to 100, with higher scores indicating better quality of life. |
| Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) composite score from baseline through 12 months after the index ablation procedure | Baseline through 12 months after the index ablation procedure | Change in EQ-5D-5L composite score from baseline to 12 months after the index ablation procedure. The EQ-5D-5L Questionnaire is a standardized instrument for measuring health status. The Chinese EQ-5D-5L value set will be used to calculate the composite score. The composite score ranges from -0.391 to 1, with higher scores indicating better health status. |
Countries
China
Contacts
CONTACTRachel Zhang
CONTACTXin Wang, MD, PHD
PRINCIPAL_INVESTIGATORLiqun Wu, PHD, MD
Ruijin Hospital
Outcome results
None listed