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
Qualifiers
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 design
Treatments tested in this trial
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
Treatment groups
433 Participants
are divided into 1 treatment groupLocations
37China
The First Affiliated Hospital of Soochow University SuzhouJiangsu, China
Beijing Anzhen Hospital of the Capital University of Medical Sciences Beijing China
Xuanwu Hospital Capital Medical University Beijing China
Huaxi Hospital of Sichuan University Chengdu China
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov