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Short term and long-term safety evaluation of HK-II biological valve after valve replacement

Short term and long-term safety evaluation of HK-II biological valve after valve replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066074
Enrollment
Unknown
Registered
2022-11-23
Start date
2022-11-28
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Valvular heart disease

Interventions

Use HK-II biological valve group:N/A

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Heart valve replacement in cardiothoracic surgery department of Nanjing Drum Tower Hospital from July 1, 2017 to July 30, 2022

Exclusion criteria

Exclusion criteria: 1. HK-II biological valve was not used during operation 2. Loss of follow-up after operation

Design outcomes

Primary

MeasureTime frame
All cause mortality;—

Secondary

MeasureTime frame
Major cardiovascular and cerebrovascular events, including: stroke (ischemic/hemorrhagic); Myocardial infarction (S-T segment elevation/non S-T segment elevation); Cerebral embolism; Other heart surgery or intervention not related to valve;Cardiac valve related complications, including: perivalvular leakage; Infected; Mechanical valve dysfunction; Biological valve decay; Valve dysfunction after repair; Embolization; Thrombosis; other;—

Countries

China

Contacts

Public ContactDongjin Wang

Nanjing Drum Tower Hospital

wangdongjin@njglyy.com13915980346

Outcome results

None listed

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