cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Overview

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.

Detailed description

The OPTION-A Study is an observational, prospective, single-arm, multi-center non-mandated post-market study. 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. The objective(s) of the OPTION-A Study is to evaluate safety and effectiveness of catheter ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent implant of Left Atrial Appendage closure (LAAC) with the WATCHMAN™ LAA Closure device in a concomitant procedure.

Interventions

• Device FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
  The 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 fe

Primary outcome measures

• Periprocedural or procedure-related Composite Serious Adverse Events will be assessed [Time frame: 30 days post index procedure]
• Acute Treatment Success will be assessed [Time frame: between index procedure and 30 days post index procedure]

Secondary outcome measures (1)

• Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed [Time frame: 1 year post index procedure]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Known or suspected atrial myxoma.
• Presence of intracardiac thrombus.
• Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device.
• Subjects with a presence of a mechanical valve prosthesis in any position.
• Subjects with a myocardial infarction within 30 days prior to enrollment.
• Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
• Any planned electrical cardioversion within 30 days following LAAC device implant.
• Subjects with a known inability to obtain vascular access.
• Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\*.
• Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present.
• Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
• Subjects who are pregnant or planning to be pregnant.
• Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 15 centers

• The First Affiliated Hospital of Soochow University — Suzhou
• Beijing Anzhen Hospital of the Capital University of Medical Sciences — Beijing
• Xuanwu Hospital Capital Medical University — Beijing
• Huaxi Hospital of Sichuan University — Chengdu
• The First Affiliated Hospital of Chengdu Medical College — Chengdu
• Guangdong Nanfang Hospital — Guangzhou
• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou
• The Affiliated Hospital of Guizhou Medical University — Guiyang
• … and 7 more centers

Japan · 11 centers

• Shonan Kamakura General Hospital — Kamakura-shi
• Sendai Kousei Hospital — Sendai
• Kurashiki Central Hospital — Kurashiki-shi
• Saitama Red Cross Hospital — Saitama
• Sakakibara Heart Institute, Sakakibara Heart Foundation — Fuchu-shi
• Kokura Memorial Hospital — Fukuoka-ken
• Yokosuka Kyosai Hospital — Kanagawa
• Kawasaki Saiwai Hospital — Kawasaki
• … and 3 more centers

Hong Kong · 4 centers

• Prince of Wales Hospital — Hong Kong
• Princess Margaret Hospital — Hong Kong
• Queen Mary Hospital — Hong Kong
• Queen Elizabeth Hospital — Kowloon

Taiwan · 4 centers

• China Medical University Hospital — Taichung
• Taichung Veterans General Hospital — Taichung
• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Malaysia · 2 centers

• Institute Jantung Negara — Kuala Lumpur
• Pusat Jantung Sarawak — Kuching

Singapore · 1 center

• Asian Heart and Vascular Centre — Singapore

Identifiers

NCT: NCT06686485 · PF316

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗