Phase
Condition
Arrhythmia
Chest Pain
Dysrhythmia
Treatment
FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinically indicated for treatment with both the FARAPULSE™ PFA system and withWATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard ofcare.
Subjects who are willing and able to provide informed consent.
Subjects who are willing and able to participate in all testing associated with thisclinical study at an approved clinical investigational center.
Subjects whose age is 18 years or above, or who are of legal age to give informedconsent specific to state and national law.
Exclusion
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 repairor 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) ortransient 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 congenitalabnormalities (severe rotational anomalies of the heart or great vessels) arepresent*.
Subjects with any contraindications to short term use of anticoagulation therapy, oraspirin 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 registrythat would directly interfere with the current study, except when the subject isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance must be reviewed by thesponsor to determine eligibility.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Soochow University
Suzhou 1886760, Jiangsu 1806260
ChinaActive - Recruiting
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing,
ChinaSite Not Available
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing 1816670,
ChinaActive - Recruiting
Huaxi Hospital of Sichuan University
Chengdu,
ChinaSite Not Available
Huaxi Hospital of Sichuan University
Chengdu 1815286,
ChinaActive - Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang,
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang 1809461,
ChinaActive - Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou 1808926,
ChinaActive - Recruiting
QiLu Hospital of ShanDong University
Jinan 1805753,
ChinaActive - Recruiting
Shanxi Cardiovascular Hospital
Taiyuan 1793511,
ChinaActive - Recruiting
Zigong First People's Hospital
Zigong 1783745,
ChinaActive - Recruiting
Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Prince of Wales Hospital
Hong Kong 1819729,
Hong KongActive - Recruiting
Princess Margaret Hospital
Hong Kong 1819729,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong 1819729,
Hong KongActive - Recruiting
Queen Elizabeth Hospital
Kowloon 1819609,
Hong KongActive - Recruiting
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa 1860291
JapanActive - Recruiting
Sendai Kousei Hospital
Sendai 2111149, Miyagi 2111888
JapanActive - Recruiting
Kurashiki Central Hospital
Kurashiki-shi, Okayama Kurashiki-shi
JapanActive - Recruiting
Saitama Red Cross Hospital
Saitama 6940394, Saitama 1853226
JapanActive - Recruiting
Sakakibara Heart Institute, Sakakibara Heart Foundation
Fuchu-shi, Tokyo 1850144
JapanActive - Recruiting
Kokura Memorial Hospital
Fukuoka-ken,
JapanActive - Recruiting
Yokosuka Kyosai Hospital
Kanagawa 1860292,
JapanActive - Recruiting
Toho University Ohashi Medical Center
Meguro-ku,
JapanActive - Recruiting
Osaka Keisatsu Hospital
Osaka,
JapanSite Not Available
Osaka Keisatsu Hospital
Osaka 1853909,
JapanActive - Recruiting
Institute Jantung Negara
Kuala Lumpur,
MalaysiaSite Not Available
Institute Jantung Negara
Kuala Lumpur 1735161,
MalaysiaActive - Recruiting
Pusat Jantung Sarawak
Kuching 1735634,
MalaysiaActive - Recruiting
Asian Heart and Vascular Centre
Singapore 1880252,
SingaporeActive - Recruiting
Taichung Veterans General Hospital
Taichung 1668399,
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei,
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341,
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei 1668341,
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei city,
TaiwanSite Not Available

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