Clinical trial NCT05263024: Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Thrombus; Embolism
Warfarin
Atrial Appendage
Surgery
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring heart valve surgery with atrial fibrillation

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

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with valvular heart disease aged between 18 and 75
2. Valvular heart disease \[Cardiovascular Surgery Volume, Clinical Diagnosis and Treatment Guidelines, Chinese Medical Association (2011 edition)\]
3. Preoperative cardiac function grade II-III (NYHA), no operation-related contraindications
4. 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:

1. Patients whose left atrial appendage has been resected or occluded
2. She had a history of open heart surgery with extensive adhesion of the pericardium
3. Patients cannot be returned due to other reasons
4. Failed to reach the end point in clinical trials of other drugs or devices
5. X-ray is contraindicated or not suitable for TEE examination
6. Those who are considered unsuitable for the clinical trial by the investigator

Primary outcomes:
measure: Success rate of auricular clip clipping
timeFrame: 12 months
measure: Clinical success rate of auricular clip
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: