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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Surgery; Thrombus; Embolism; Warfarin; Atrial Appendage
• Intervention / Treatment: Device: atrial appendage clip

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 Type: Observational
• Enrollment (Anticipated): 118

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring heart valve surgery with atrial fibrillation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: atrial appendage clip; 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	Device: atrial appendage clip; During cardiac surgery, atrial fibrillation patients were treated with atrial appendage clipping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of auricular clip clipping	Success rate of auricular clip clipping	12 months
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 21, 2022
• Primary Completion (Anticipated): March 22, 2025
• Study Completion (Anticipated): March 22, 2027

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Heart Diseases; Embolism; Atrial Fibrillation; Thrombosis; Thromboembolism; Heart Valve Diseases
• Other Study ID Numbers: 2021-53-TYH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No