cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Recruiting · NCT06686485 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boston Scientific Corporation
View the official record on ClinicalTrials.gov →Interventions studied
FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
37 locations listed.
- 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
- The First Affiliated Hospital of Chengdu Medical College - Chengdu, China
- Kokura Memorial Hospital - Fukuoka-ken, Japan
- Guangdong Nanfang Hospital - Guangzhou, China
- The Third Affiliated Hospital of Guangzhou Medical University - Guangzhou, China
- The Affiliated Hospital of Guizhou Medical University - Guiyang, China
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine - Hangzhou, China
- Prince of Wales Hospital - Hong Kong, Hong Kong
- Princess Margaret Hospital - Hong Kong, Hong Kong
- Queen Mary Hospital - Hong Kong, Hong Kong
- QiLu Hospital of ShanDong University - Jinan, China
- Yokosuka Kyosai Hospital - Kanagawa, Japan
- Kawasaki Saiwai Hospital - Kawasaki, Japan
- Queen Elizabeth Hospital - Kowloon, Hong Kong
- Institute Jantung Negara - Kuala Lumpur, Malaysia
- Pusat Jantung Sarawak - Kuching, Malaysia
- First People's Hospital of Yunnan Province - Kunming, China
- Toho University Ohashi Medical Center - Meguro-ku, Japan
- Affiliated Hospital of Nantong University - Nantong, China
- Osaka Keisatsu Hospital - Osaka, Japan
- Asian Heart and Vascular Centre - Singapore, Singapore
- China Medical University Hospital - Taichung, Taiwan
- Taichung Veterans General Hospital - Taichung, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- Shanxi Cardiovascular Hospital - Taiyuan, China
- Yokohama city minato Red Cross Hospital - Yokohama, Japan
- Zhuhai People's Hospital - Zhuhai, China
- Zigong First People's Hospital - Zigong, China
- The First Affiliated Hospital of Soochow University - Suzhou, Jiangsu, China
- Shonan Kamakura General Hospital - Kamakura-shi, Kanagawa, Japan
- Sendai Kousei Hospital - Sendai, Miyagi, Japan
- Kurashiki Central Hospital - Kurashiki-shi, Okayama Kurashiki-shi, Japan
- Saitama Red Cross Hospital - Saitama, Saitama, Japan
- Sakakibara Heart Institute, Sakakibara Heart Foundation - Fuchu-shi, Tokyo, Japan