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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05263024
Enrollment
118
Registered
2022-03-02
Start date
2022-02-21
Completion date
2027-03-22
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEatrial appendage clip

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

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate of auricular clip clipping12 monthsSuccess rate of auricular clip clipping
Clinical success rate of auricular clip12 monthsRate of patients without ischemic stroke, TIA, or systemic embolism 12 months after cardiac and auricular clipping

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026