VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）

VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）

This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.

This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.

Inclusion Criteria:

• Must meet 1, 2, 3, 4 or 1, 5 to be selected:

  1. Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions*;

  2. Be able to get in touch with the patient or his legal guardian/relative;

  3. Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;

  4. Sign the informed consent form;

  5. Patients who are known to have died.

     • 4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.

Exclusion Criteria:

1. Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;
2. The investigator judges that the patient's compliance is poor and the study cannot be completed as required.