Actively Recruiting
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2023-09-01
244
Participants Needed
14
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
CONDITIONS
Official Title
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-60 years
- Able to understand the purpose of the study and voluntarily agree to participate by signing informed consent
- Patent foramen ovale confirmed by transthoracic or transesophageal echocardiography, or by right-heart acoustic contrast showing medium or large right-to-left shunt
- Meet clinical indications for patent foramen ovale closure with one or more of the following: cryptogenic stroke with clinical risk factors, cryptogenic stroke with anatomical risk factors, cryptogenic stroke with deep vein thrombosis or pulmonary embolism unsuitable for anticoagulant therapy, or recurrent cryptogenic stroke despite antiplatelet or anticoagulant therapy
You will not qualify if you...
- Carotid artery stenosis greater than 50% based on imaging
- Large cerebral infarction within 4 weeks with specified imaging criteria
- Presence of intracardiac thrombosis, tumor, or vegetations
- Acute myocardial infarction or unstable angina within past 6 months
- Left ventricular aneurysm or wall motion disorder
- Severe mitral or aortic valve disease or prior valve replacement
- Dilated cardiomyopathy with ejection fraction under 35% or severe heart failure
- Right-to-left shunt from causes other than patent foramen ovale
- Atrial fibrillation or flutter
- Pregnancy or planning pregnancy during the trial
- Active endocarditis, untreated infections, or bleeding disorders
- Pulmonary hypertension or special channel patent foramen ovale
- Severe liver or kidney impairment
- Uncontrolled high blood pressure
- Contraindications to antiplatelet or anticoagulant therapy
- Poorly controlled vascular diseases like coronary heart disease, hypertension, or diabetes
- Unsuitability for patent foramen ovale occluder implantation
- Presence of thrombosis on implantation route
- Malignant tumors or life expectancy under 2 years
- Inability to complete follow-up
- Participation in other clinical trials within 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
2
Fuwai Hospital ，CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Not Yet Recruiting
3
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
4
Meizhou people'Hospital
Meizhou, Guangdong, China, 514031
Actively Recruiting
5
The Second XiangYa Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
6
The Third XiangYa Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
7
The First Hospital Of JiLin Universitv
Changchun, Jilin, China, 130021
Not Yet Recruiting
8
General Hospital of Northern Theater Command
Shenyang, Liaoning, China, 110015
Not Yet Recruiting
9
Qilu Hospitalof Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
10
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, China, 250014
Not Yet Recruiting
11
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China, 650000
Actively Recruiting
12
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
13
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Not Yet Recruiting
14
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiangbin Pan, Doctor
CONTACT
H
Hongbo Yang, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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