VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

May 31, 2020 updated by: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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 a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.

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.
Interventional

Enrollment (Anticipated)

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.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Fuwai Hospital
        • Contact:
          • Yongjian Wu, Prof
          • Phone Number: 13701387189
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhongshan Hospital
        • Contact:
          • Junbo Ge, Prof
          • Phone Number: 13901977506
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Mao Chen, Prof
          • Phone Number: 18980602046
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Jian-An Wang, Prof
          • Phone Number: 13805786328

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age≥70 years;
  2. Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area<0.8cm² (or EOA index<0.5cm²/m²);
  3. NYHA≥II class;
  4. Estimated life-expectancy>12 months after implantation of the prosthetic valve;
  5. Anatomically suitable for the transcatheter aortic valve implantation procedure;
  6. The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.

Exclusion Criteria:

  1. Acute myocardial infarction (MI) in last 30 days before the treatment;
  2. Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
  3. Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
  4. Previous implantation of heart valve at any position；
  5. Hemodynamic instability requiring mechanical hemodynamic support devices;
  6. Need for emergency surgery for any reason;
  7. Hypertrophic cardiomyopathy with obstruction;
  8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction;
  9. Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
  10. Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
  11. Congenital aortic valve stenosis or unicuspid aortic valve;
  12. Vascular diseases or anatomical condition preventing the device access;
  13. Active endocarditis or other active infections at the time of treatment;
  14. Participating in another trial and the primary endpoint is not achieved.
  15. Inability to comply with the clinical investigation follow-up or other requirements.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Single arm clinical investigation
Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System
Device: VitaFlow™ II Transcatheter Aortic Valve System
VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire

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
Rate of all-cause mortality at 12 months post implantation
Time Frame: 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
12 months post implantation

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
Valve function-mean prosthetic valve gradient
Time Frame: at 30 days, 6 months, and 1 year post implantation
Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)
at 30 days, 6 months, and 1 year post implantation
Valve function- effective orifice area
Time Frame: at 30 days, 6 months, and 1 year post implantation
Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)
at 30 days, 6 months, and 1 year post implantation
Valve function- degree of prosthetic valve regurgitation
Time Frame: at 30 days, 6 months, and 1 year post implantation
Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
at 30 days, 6 months, and 1 year post implantation
Rate of safety events according to VARC2
Time Frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, conduction disturbance and arrhythmias, and new permanent pacemaker implantation
at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of other TAVI-related complications
Time Frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, and TAV-in-TAV
at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of major adverse cardiac and cerebrovascular events(MACCE)
Time Frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances
at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of device success
Time Frame: at immediate post implantation
Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function
at immediate post implantation
Rate of balloon pre-dilation success
Time Frame: at immediate post implantation
Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter
at immediate post implantation
Rate of balloon post-dilation success
Time Frame: at immediate post implantation
Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter
at immediate post implantation
Rate of procedure success
Time Frame: at immediate post implantation
Rate of procedure success, assessed by the device success and the peri-procedural complications
at immediate post implantation

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.

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 (Actual)

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.
January 31, 2018

Primary Completion (Anticipated)

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.
January 31, 2022

Study Completion (Anticipated)

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.
January 31, 2027

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).
May 27, 2020

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.
May 31, 2020

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.
June 4, 2020

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.
June 4, 2020

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.
May 31, 2020

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.
May 1, 2020

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.
  • SUPERIOR-2017

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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