Clinical trial NCT05977257: VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
Official title: VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Lead sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: All cause mortality
timeFrame: 7years after the operation
Secondary outcomes:
measure: Cardiac death
timeFrame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
measure: Stroke
timeFrame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
measure: valve-related rehospitalization
timeFrame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
measure: Serious Adverse Event
timeFrame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
measure: Blood pressure
timeFrame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
measure: The 12-Item Short Form Health Survey (SF-12)
timeFrame: 6years, 7years, 8 years, 9 years and 10 years after the operation
measure: Mean transvalvular pressure gradient
timeFrame: 7years,and 10 years after the operation
measure: Effective orifice area
timeFrame: 7years,and 10 years after the operation
measure: Peak velocity
timeFrame: 7years,and 10 years after the operation
measure: class of Paravalvular leak
timeFrame: 7years,and 10 years after the operation
measure: class of Aortic regurgitation
timeFrame: 7years,and 10 years after the operation
measure: New York Heart Association Class for heart function
timeFrame: 7years,and 10 years after the operation
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 7years,and 10 years after the operation
measure: Natriuretic peptide tests ( NT Pro-BNP or BNP)
timeFrame: 7years,and 10 years after the operation
measure: moderate and severe structural valve deterioration SVD
timeFrame: 7years,and 10 years after the operation
measure: bioprosthetic valve failure，BVF
timeFrame: 7years,and 10 years after the operation
measure: All cause mortality
timeFrame: 6 years, 8 years, 9 years and 10 years after the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai CVD Hospital of Chinese Academy of Medical Sciences
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: Fudan University
name: Daxin Zhou
role: PRINCIPAL_INVESTIGATOR
References: