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

July 28, 2023 updated by: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Fuwai CVD Hospital of Chinese Academy of Medical Sciences
        • Contact:
          • Yongjian Wu
      • Chengdu, China
        • West China Hospital, Sichuan University
        • Contact:
          • Yuan Feng
      • Hangzhou, China
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • jianan Wang
      • Shanghai, China
        • Zhongshan Hospital Fudan University
        • Contact:
          • Daxin Zhou
        • Principal Investigator:
          • Daxin Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non Interventional long term safety follow up
Device: VitaFlow® Transcatheter Aortic Valve Replacement System
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 7years after the operation
rate of all cause mortality
7years after the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of Cardiac death
6 years, 7 years, 8 years, 9 years and 10 years after the operation
Stroke
Time Frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of stroke
6 years, 7 years, 8 years, 9 years and 10 years after the operation
valve-related rehospitalization
Time Frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of valve-related rehospitalization
6 years, 7 years, 8 years, 9 years and 10 years after the operation
Serious Adverse Event
Time Frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
rate of Serious Adverse Event
6 years, 7 years, 8 years, 9 years and 10 years after the operation
Blood pressure
Time Frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Systolic and Diastolic Blood Pressure
6 years, 7 years, 8 years, 9 years and 10 years after the operation
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
6years, 7years, 8 years, 9 years and 10 years after the operation
Mean transvalvular pressure gradient
Time Frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
7years,and 10 years after the operation
Effective orifice area
Time Frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
7years,and 10 years after the operation
Peak velocity
Time Frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
7years,and 10 years after the operation
class of Paravalvular leak
Time Frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
7years,and 10 years after the operation
class of Aortic regurgitation
Time Frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
7years,and 10 years after the operation
New York Heart Association Class for heart function
Time Frame: 7years,and 10 years after the operation
NYHA class
7years,and 10 years after the operation
Kansas City Cardiomyopathy Questionnaire
Time Frame: 7years,and 10 years after the operation
Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better
7years,and 10 years after the operation
Natriuretic peptide tests ( NT Pro-BNP or BNP)
Time Frame: 7years,and 10 years after the operation
blood test
7years,and 10 years after the operation
moderate and severe structural valve deterioration SVD
Time Frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
7years,and 10 years after the operation
bioprosthetic valve failure，BVF
Time Frame: 7years,and 10 years after the operation
Transthoracic Echocardiogram test
7years,and 10 years after the operation
All cause mortality
Time Frame: 6 years, 8 years, 9 years and 10 years after the operation
rate of all cause mortality
6 years, 8 years, 9 years and 10 years after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daxin Zhou, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VITAL-2023-192R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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