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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230030 / PAS001 |
| Date Original Protocol Accepted |
06/18/2024
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| Date Current Protocol Accepted |
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| Study Name |
ADVENT Post-Approval Study
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| Device Name |
FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, FARASTAR™ Pulsed Field Ablation Generator, FARASTAR™ Recording System Module, FARASTAR™ Stimulation Module Cable, FARASTAR™ EGM Cable, FARASTAR™ Stimulation Module Male Cable, FARASTAR™ Stimulation Module Female Cable, FARASTAR™ Stimulation Module Female Cable, FARASTAR™ Stimulation Module Y-Cable Long, FARASTAR™ Stimulation Module Y-Cable Short, FARASTAR™ Recording System Module Catheter Pin Cable, FARASTAR™ Recording System Module ECG Trunk Cable (AAMI/IEC), FARASTAR™ Recording System Module ECG Output Cable (AAMI/IEC), FARASTAR™ Recording System Module EGM Input Module, FARASTAR™ SNAP CABLE R/L – (AAMI/IEC), FARASTAR™ SNAP CABLE V SET – (AAMI/IEC))
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| Clinical Trial Number(s) |
NCT04612244
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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 |
The objective of the ADVENT PAS study is to collect clinical data on safety, effectiveness, and procedural success of Boston Scientific FARAPULSE PFA System when used to perform pulmonary vein isolation (PVI) in the ablative treatment of de novo drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF). The study is designed as a prospective, non-randomized, multi-center, global, single arm registry.
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| Study Population |
Patients being treated for paroxysmal atrial fibrillation (PAF). The study will include a diverse (i.e. race ethnicity, gender) patient population.
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| Sample Size |
Number of subjects: A minimum of 220 de novo treatment subjects with at least 100 subjects participating in the LUX-Dx Sub-study
Assumptions for sample size estimation: Performance goal of 11% for the primary safety endpoint and a performance goal of 50% for the primary effectiveness endpoint. Power of 0.85 to reject the null hypothesis at an alpha of 0.025.
Number of sites: Up to 75 centers globally
Sites location: At least 50% of study sites will be in the United States
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| Key Study Endpoints |
Safety Endpoints
Primary:
Primary safety events will consist of a composite of the following serious procedure-related and device-related adverse events:
Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later, include:
• Death
• Myocardial infarction (MI)
• Persistent phrenic nerve palsy*
• Stroke/Cerebrovascular accident (CVA)
• Transient ischemic attack (TIA)
• Peripheral or organ thromboembolism
• Cardiac tamponade / perforation
• Pericarditis
• Pulmonary edema
• Serious vascular access complications
• Heart block
• Gastric motility / pyloric spasm disorders
• Severe hemolysis with subsequent renal injury
* A non-recovered phrenic nerve injury at 12 months post-Index Procedure will count as primary endpoint. The study will collect information on phrenic nerve palsy observed before the end of the Index Procedure, and in case it occurred, will track information for potential recovery during the study visits.
Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure:
• Atrial esophageal fistula
• Pulmonary vein stenosis (greater than or equal to 70% reduction of diameter)
Definition of the safety events can be found in Table 5.2-1.
Effectiveness Endpoints
Primary: The primary effectiveness endpoint is treatment success in treated subjects, defined as:
• Acute Procedural Success* AND
• Chronic Success, defined as freedom from the following:
o After the Blanking Period up to the 12-Month Follow-up visit:
¿ Occurrence of any Detectable AF, AFL, AT
• greater than or equal to 30 seconds in duration from any approved** clinical recording devices considered standard of care at the study center (excluding implantable loop recorders)** or
• greater than or equal to 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
¿ Following interventions:
• Any cardioversion for AF, AFL or AT
• Prescribed a higher dose of any failed Class I or III AAD documented at baseline or any new Class I or III AAD
• Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter only)***
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| Follow-up Visits and Length of Follow-up |
All subjects treated with the FARAPULSE PFA System will be followed for 36 months. Subjects with a pre-existing LUX-Dx or a LUX-Dx inserted within 7 days of the ablation procedure will have arrhythmia recurrence monitored remotely via the LATITUDE Clarity System to assess for arrhythmia recurrence for up to 3 years.
Subjects will undergo the index procedure and be followed at pre-discharge, 3 Month, 6 Month, 12 Month, 24 Month, and 36 Month visits.
Attempt subjects will receive a phone call at 30 days post-procedure to verify adverse events and complications.
The total study duration is expected to take 5 years
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