Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis
1 other identifier
observational
118
0 countries
N/A
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 achieve clinically accurate treatment, and to establish the heart valve, the usefulness and universality of Warfarin's anticoagulant model were verified by the specimen library
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2022
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2022
CompletedStudy Start
First participant enrolled
February 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2027
ExpectedMarch 2, 2022
February 1, 2022
3.1 years
February 20, 2022
February 20, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Success rate of auricular clip clipping
Success rate of auricular clip clipping
12 months
Clinical success rate of auricular clip
Rate of patients without ischemic stroke, TIA, or systemic embolism 12 months after cardiac and auricular clipping
12 months
Study Arms (2)
left atrial appendage clip
Cardiac valvular patients complicated with atrial fibrillation need cardiac valvular surgery, according to the patient's wishes, cardiac auricular clamp at the same time
Left atrial appendage treated with conventional methods
Valvular heart disease with atrial fibrillation requires valvular heart surgery and left atrial ligation
Interventions
During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping
Eligibility Criteria
Patients requiring heart valve surgery with atrial fibrillation
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2022
First Posted
March 2, 2022
Study Start
February 21, 2022
Primary Completion
March 22, 2025
Study Completion (Estimated)
March 22, 2027
Last Updated
March 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share