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Study on the significance of auricular clip in the prevention and treatment of atrial thrombosis in valvular heart disease and related percision treatment technology

Study on the significance of auricular clip in the prevention and treatment of atrial thrombosis in valvular heart disease and related percision treatment technology

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056484
Enrollment
Unknown
Registered
2022-02-06
Start date
2022-01-25
Completion date
Unknown
Last updated
2024-10-07

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

Conditions

an auricular thrombus from valvular heart disease

Interventions

Traditional treatment of the left atrial appendage:None
The implanted treatment of left atrial appendage occluder:None

Sponsors

The second affiliated hospital of Nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The age of patients of valvular heart disease between 18 and 75 years old; 2. Valvular Heart Disease [Chinese Medical Association Clinical Diagnosis and Tieatment Guidelines Cardiovascular Surgery Volume(2011 edition); 3.Preoperative cardiac grade I-III(NYHA),no operation-related contraindications; 4.Understand the nature of this study and agree to participate in all the terms of this study,sign the informed consent,agree to accept the postoperative treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1.Left atrial appendage has been resected or left atrial appendage occluder has been implanted; 2.She had a history of open heart surgery with extensive adhesion of pericardium; 3.Patients can not be retured due to other reasons; 4.Failed to reach the end point of 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 investgator.

Design outcomes

Primary

MeasureTime frame
The type of the left atrial appendage;The success rate of clipping of the left atrial appendage was followed up for 12 months after operation;Clinical success rate of 12-month follow-up after left atrial appendage clipping;

Secondary

MeasureTime frame
Performance evaluation of left atrial appendage clip;The incidence of stroke and transient cerebral ischemia after left atrial appendage clipping;Perioperative clinical success rate of left atrial appendage;Incidence rate of MACCE;

Countries

China

Contacts

Public ContactTang Yanhua

The Second Affiliated Hospital of Nanchang University

tyh6565@163.com+86 13517081828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026