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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240013 / PAS001 |
| Date Original Protocol Accepted |
02/03/2025
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| Date Current Protocol Accepted |
05/30/2025
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| Study Name |
SPHERE Per-AF Post-Approval Study
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| Device Name |
Sphere-9 Catheter and Affera Ablation System
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| Clinical Trial Number(s) |
NCT05120193
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Evaluate primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.
Estimate the 36-month freedom from atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) recurrence following ablation procedure using the Sphere-9™ Catheter and Affera™ Ablation System.
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| Study Population |
Subjects greater tha or equal to 18 years of age who have a recommendation for an ablation with the Sphere-9™ Catheter and Affera™ Ablation System.
Inclusion Criteria * A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months).
-Refractory (i.e., not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug.
-Patient is greater than or equal to 18 years of age.
-Planned de novo pulmonary vein isolation (PVI) procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System.
-Patient is willing and able to comply with study requirements and give informed consent.
Exclusion Criteria * Long-standing persistent AF (continuous AF sustained >12 months).
-Prior left atrial catheter or surgical ablation.
-Life expectancy <36 months.
-Presence 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).
-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 the sponsor.
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| Sample Size |
Number of subjects: 200
Assumptions for sample size estimation: 175 subjects treated.
Number of sites: 15
Sites location: All subjects will be enrolled within the United States of America.
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| Key Study Endpoints |
Safety Endpoints
Primary: Estimate the primary safety adverse event rate for ablation using the Sphere-9™ Catheter and Affera Ablation System.
The following device- and/or procedure-related serious adverse events (SAEs) following the index ablation procedure will be considered a primary safety event:
Within 7 Days: * Death
-Myocardial Infarction
-Phrenic nerve paralysis (ongoing at 6 months)
-Transient ischemic attack (TIA)
-Stroke/cerebrovascular accident (CVA)
-Thromboembolism
-Major vascular access complications/bleeding
-Heart block
-Gastroparesis
-Severe pericarditis
-Hospitalization (initial or prolonged) due to cardiovascular or pulmonary AE‡
Within 30 days: * Cardiac Tamponade/perforation
Within 90 days: * Atrio-esophageal fistula
Within 180 days: * Pulmonary vein stenosis
‡ Excludes hospitalization due to AF/AT/AFL recurrence
Effectiveness Endpoints
Primary: The primary effectiveness endpoint is defined as freedom from any of the following through 36 months: * Documented recurrent AF/AT/AFL after a 90-day blanking period
-Minimum of 10 seconds on 12-lead ECG
-Minimum of 30 seconds on 24-hour Holter
-Minimum of 30 seconds on other cardiac rhythm monitoring device (e.g. event monitor, TTM)
-Repeat ablation for the treatment of AF/AT/AFL after a 90-day blanking period
-Cardioversion for the treatment of AF/AT/AFL after a 90-day blanking period
Blanking period is defined as the 90 days post study index ablation procedure. Recurrent AF/AT/AFL or treatments for AF/AT/AFL during the 90-day blanking period do not count towards the primary effectiveness endpoint. Subjects may be managed with medications and cardioversions per standard of care (SOC) during the 90-day blanking period. Repeat ablation during the blanking period is discouraged.
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| Follow-up Visits and Length of Follow-up |
Once enrolled, a subject will be assessed at the following visits: * Enrollment/Baseline
Ablation procedure
6 months
12 months
24 months
36 months
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