Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis

Not yet recruiting

• Conditions: Surgery; Atrial Fibrillation; Warfarin; Atrial Appendage; Thrombus; Embolism
• Interventions: Device: atrial appendage clip

• Registration Number: NCT05263024
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-20
• Last Update Submitted: 2022-02-20
• Study Start: 2022-02-21
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02
• Primary Completion: 2025-03-22
• Study Completion: 2027-03-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
left atrial appendage clip	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	atrial appendage clip	Valvular heart disease with atrial fibrillation requires valvular heart surgery and left atrial ligation

Primary Outcome Measures

Name	Time	Method
Clinical success rate of auricular clip	12 months	Rate of patients without ischemic stroke, TIA, or systemic embolism 12 months after cardiac and auricular clipping
Success rate of auricular clip clipping	12 months	Success rate of auricular clip clipping