Status:
NOT_YET_RECRUITING
Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis
Lead Sponsor:
Second Affiliated Hospital of Nanchang University
Conditions:
Atrial Fibrillation
Thrombus; Embolism
Eligibility:
All Genders
18-75 years
Brief Summary
To evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to...
Detailed Description
Atrial fibrillation (AF) is a common arrhythmia. The risk of ischemic stroke in AF patients is 4-5 times higher than that in non-af patients, and leads to nearly 20% mortality and nearly 60% disabilit...
Eligibility Criteria
Inclusion
- Patients with valvular heart disease aged between 18 and 75
- Valvular heart disease \[Cardiovascular Surgery Volume, Clinical Diagnosis and Treatment Guidelines, Chinese Medical Association (2011 edition)\]
- Preoperative cardiac function grade II-III (NYHA), no operation-related contraindications
- Understand the nature of this study, agree to participate in all terms of this study, sign informed consent, agree to accept postoperative treatment plan and follow-up requirements, and cooperate to complete follow-up
Exclusion
- Patients whose left atrial appendage has been resected or occluded
- She had a history of open heart surgery with extensive adhesion of the pericardium
- Patients cannot be returned due to other reasons
- Failed to reach the end point in clinical trials of other drugs or devices
- X-ray is contraindicated or not suitable for TEE examination
- Those who are considered unsuitable for the clinical trial by the investigator
Key Trial Info
Start Date :
February 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 22 2027
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT05263024
Start Date
February 21 2022
End Date
March 22 2027
Last Update
March 2 2022
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