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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05263024
• Other study ID #: 2021-53-TYH
• Status: Not yet recruiting
• Start date: February 21, 2022
• Est. completion date: March 22, 2027

Study information

• Verified date: February 2022
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: March 22, 2027
• Est. primary completion date: March 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Appendage
• Atrial Fibrillation
• Embolism
• Heart Diseases
• Heart Valve Diseases
• Surgery
• Thromboembolism
• Thrombosis
• Thrombus; Embolism
• Warfarin

Intervention

Device:
• atrial appendage clip
During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of auricular clip clipping	Success rate of auricular clip clipping	12 months
Primary	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