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NCT Number: NCT05977257

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai CVD Hospital of Chinese Academy of Medical Sciences, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must meet 1, 2, 3, 4 or 1, 5 to be selected:
  • Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions*;
  • Be able to get in touch with the patient or his legal guardian/relative;
  • 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;
  • Sign the informed consent form;
  • 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

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

Treatment and study plan

VitaFlow® Transcatheter Aortic Valve Replacement System

Device

This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial

Primary outcomes

  1. All cause mortality

    Time frame: 7years after the operation

    rate of all cause mortality

Secondary outcomes

  1. Cardiac death

    Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation

    rate of Cardiac death

  2. Stroke

    Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation

    rate of stroke

  3. valve-related rehospitalization

    Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation

    rate of valve-related rehospitalization

  4. Serious Adverse Event

    Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation

    rate of Serious Adverse Event

  5. Blood pressure

    Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation

    Systolic and Diastolic Blood Pressure

  6. The 12-Item Short Form Health Survey (SF-12)

    Time frame: 6years, 7years, 8 years, 9 years and 10 years after the operation

    Scores range from 0 to 100, higher scores are better

  7. Mean transvalvular pressure gradient

    Time frame: 7years,and 10 years after the operation

    Transthoracic Echocardiogram test

  8. Effective orifice area

    Time frame: 7years,and 10 years after the operation

    Transthoracic Echocardiogram test

  9. Peak velocity

    Time frame: 7years,and 10 years after the operation

    Transthoracic Echocardiogram test

  10. class of Paravalvular leak

    Time frame: 7years,and 10 years after the operation

    Transthoracic Echocardiogram test

  11. class of Aortic regurgitation

    Time frame: 7years,and 10 years after the operation

    Transthoracic Echocardiogram test

  12. New York Heart Association Class for heart function

    Time frame: 7years,and 10 years after the operation

    NYHA class

  13. Kansas City Cardiomyopathy Questionnaire

    Time frame: 7years,and 10 years after the operation

    Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better

  14. Natriuretic peptide tests ( NT Pro-BNP or BNP)

    Time frame: 7years,and 10 years after the operation

    blood test

  15. moderate and severe structural valve deterioration SVD

    Time frame: 7years,and 10 years after the operation

    Transthoracic Echocardiogram test

  16. bioprosthetic valve failure,BVF

    Time frame: 7years,and 10 years after the operation

    Transthoracic Echocardiogram test

  17. All cause mortality

    Time frame: 6 years, 8 years, 9 years and 10 years after the operation

    rate of all cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

JIATONG ZHANG

CONTACT

[email protected]

+8617797187661

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Industry

Registry information

Acronym: VITAL

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Aug 4, 2023
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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