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

NCT ID: NCT05263024

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2027-03-22

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.

Conditions

Atrial Fibrillation; Thrombus; Embolism; Warfarin; Atrial Appendage; Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

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

atrial appendage clip

Intervention Type: DEVICE

During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping

Left atrial appendage treated with conventional methods

Valvular heart disease with atrial fibrillation requires valvular heart surgery and left atrial ligation

atrial appendage clip

Intervention Type: DEVICE

During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping

Interventions

atrial appendage clip

During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2021-53-TYH

Identifier Type: -

Identifier Source: org_study_id