Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: atrial appendage clip.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Thrombus; Embolism, Warfarin, Atrial Appendage. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis and the Related Precision Treatment Technique
Overview
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
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% disability. Atrial fibrillation is associated with valvular disease and atrial fibrillation in about 30-70% of patients with valvular heart disease. Left atrial thrombus occurs in 15-25% of patients with atrial fibrillation. More than 90% of patients with atrial thrombus is located in the left atrial appendage. In patients with valvular atrial fibrillation, the left atrial appendage is clamped at the same time of valvular surgery to avoid recurrence of atrial thrombus-related stroke. In this clinical trial, the left atrial appendage was used to clamp the prethrombotic site of the heart to prevent stroke and improve the prognosis.
Interventions
- Device atrial appendage clip
During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping
Primary outcome measures
- Success rate of auricular clip clipping [Time frame: 12 months]
- Clinical success rate of auricular clip [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05263024 · 2021-53-TYH