Phase
Condition
Cardiac Disease
Atrial Fibrillation
Chest Pain
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 active conditions (e.g. infection, bleeding disorder, unstableangina) are present.
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, Jiangsu
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University
Suzhou 1886760, Jiangsu 1806260
ChinaSite Not Available
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing,
ChinaActive - Recruiting
Xuanwu Hospital Capital Medical University
Beijing,
ChinaActive - Recruiting
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing 1816670,
ChinaActive - Recruiting
Xuanwu Hospital Capital Medical University
Beijing 1816670,
ChinaSite Not Available
Huaxi Hospital of Sichuan University
Chengdu,
ChinaActive - Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu,
ChinaActive - Recruiting
Huaxi Hospital of Sichuan University
Chengdu 1815286,
ChinaSite Not Available
Guangdong Nanfang Hospital
Guangzhou,
ChinaActive - Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaActive - Recruiting
Guangdong Nanfang Hospital
Guangzhou 1809858,
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang,
ChinaActive - Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang 1809461,
ChinaSite Not Available
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaActive - Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou 1808926,
ChinaSite Not Available
QiLu Hospital of ShanDong University
Jinan,
ChinaActive - Recruiting
QiLu Hospital of ShanDong University
Jinan 1805753,
ChinaSite Not Available
First People's Hospital of Yunnan Province
Kunming,
ChinaActive - Recruiting
Affiliated Hospital of Nantong University
Nantong,
ChinaActive - Recruiting
Shanxi Cardiovascular Hospital
Taiyuan,
ChinaActive - Recruiting
Shanxi Cardiovascular Hospital
Taiyuan 1793511,
ChinaSite Not Available
Zhuhai People's Hospital
Zhuhai,
ChinaActive - Recruiting
Zigong First People's Hospital
Zigong,
ChinaActive - Recruiting
Zigong First People's Hospital
Zigong 1783745,
ChinaSite Not Available
Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Princess Margaret Hospital
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong,
Hong KongActive - Recruiting
Prince of Wales Hospital
Hong Kong 1819729,
Hong KongActive - Recruiting
Princess Margaret Hospital
Hong Kong 1819729,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong 1819729,
Hong KongActive - Recruiting
Queen Elizabeth Hospital
Kowloon,
Hong KongActive - Recruiting
Queen Elizabeth Hospital
Kowloon 1819609,
Hong KongSite Not Available
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa
JapanActive - Recruiting
Sendai Kousei Hospital
Sendai, Miyagi
JapanActive - Recruiting
Sendai Kousei Hospital
Sendai 2111149, Miyagi 2111888
JapanSite Not Available
Kurashiki Central Hospital
Kurashiki-shi, Okayama Kurashiki-shi
JapanActive - Recruiting
Saitama Red Cross Hospital
Saitama, Saitama
JapanActive - Recruiting
Saitama Red Cross Hospital
Saitama 6940394, Saitama 1853226
JapanSite Not Available
Sakakibara Heart Institute, Sakakibara Heart Foundation
Fuchu-shi, Tokyo
JapanActive - Recruiting
Kokura Memorial Hospital
Fukuoka-ken,
JapanActive - Recruiting
Yokosuka Kyosai Hospital
Kanagawa,
JapanActive - Recruiting
Yokosuka Kyosai Hospital
Kanagawa 1860292,
JapanSite Not Available
Kawasaki Saiwai Hospital
Kawasaki,
JapanActive - Recruiting
Toho University Ohashi Medical Center
Meguro-ku,
JapanActive - Recruiting
Osaka Keisatsu Hospital
Osaka,
JapanActive - Recruiting
Osaka Keisatsu Hospital
Osaka 1853909,
JapanSite Not Available
Yokohama city minato Red Cross Hospital
Yokohama,
JapanActive - Recruiting
Institute Jantung Negara
Kuala Lumpur,
MalaysiaActive - Recruiting
Institute Jantung Negara
Kuala Lumpur 1735161,
MalaysiaSite Not Available
Pusat Jantung Sarawak
Kuching,
MalaysiaActive - Recruiting
Pusat Jantung Sarawak
Kuching 1735634,
MalaysiaSite Not Available
Asian Heart and Vascular Centre
Singapore,
SingaporeActive - Recruiting
Asian Heart and Vascular Centre
Singapore 1880252,
SingaporeSite Not Available
China Medical University Hospital
Taichung,
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung,
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung 1668399,
TaiwanSite Not Available
National Taiwan University Hospital
Taipei,
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei,
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei 1668341,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341,
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei city,
TaiwanSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.