cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care.
Subjects who are willing and able to provide informed consent.
Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.
Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Disqualifiers
Subjects who underwent prior AF ablation procedure.
Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
Already surgically closed or otherwise excluded LAA.
The LAA anatomy does not accommodate a Closure Device.
Trial population
Subjects enrolled in the OPTION-A study will be clinically indicated for an Atrial Fibrillation ablation procedure utilizing the FARAPULSE PFA System as well as implantation of the WATCHMAN device per physician's medical judgement, and according to the hospitals' standard of care during the same procedure. The subjects selected for participation in the study will be from the investigator's general patient population. The investigator or designee has the responsibility for screening all potential subjects and selecting those who meet study eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
DeviceThe FARAPULSE™ PFA System consists of the FARAWAVE™ Pulsed Field Ablation Catheter, the FARASTAR™ Pulsed Field Ablation Generator, and the FARADRIVE™ Steerable Sheath. The WATCHMAN LAA Closure Technology consists of the WATCHMAN Access System (which consists of the Access Sheath and Dilator and the WATCHMAN Delivery System (which consists of the delivery catheter and the pre-loaded closure device). The WATCHMAN Access System and WATCHMAN Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium.
Treatment groups
433 Participants
are divided into 1 treatment groupGroup A: Treatment Subjects1 intervention
Trial outcomes
Primary outcomes
1
Periprocedural or procedure-related Composite Serious Adverse Events will be assessed
The primary safety endpoint (PSE) is the proportion of subjects with one or more of the periprocedural device or procedure-related Composite Serious Adverse Events (CSAEs) assessed at 30 days following the Index Procedure.
Time frame
30 days post index procedure2
Acute Treatment Success will be assessed
The primary effectiveness endpoint (PEE) is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥1 PFA application and who have a WATCHMAN attempted or implanted.
Time frame
between index procedure and 30 days post index procedureSecondary outcomes
1
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed at 360 days following the Index Procedure
Time frame
1 year post index procedureSponsors and contacts
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Source ClinicalTrials.gov