NCT04414865

Brief Summary

The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Apr 2020Dec 2027

Study Start

First participant enrolled

April 26, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Expected
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

May 26, 2020

Last Update Submit

May 31, 2020

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Rate of all-cause mortality at 12 months post implantation

    Rate of all-cause mortality including cardiovascular and non-cardiovascular death

    12 months post implantation

Secondary Outcomes (9)

  • Valve function-mean transvalvular gradient

    at discharge, 30 days, 1 year and annually up to 5 years post implantation

  • Valve function-effective orifice area

    at discharge, 30 days, 1 year and annually up to 5 years post implantation

  • Valve function-degree of prosthetic valve regurgitation

    at discharge, 30 days, 1 year and annually up to 5 years post implantation

  • Rate of safety events according to VARC2

    at immediate, 30 days, 1 year and annually up to 5 years post implantation

  • Rate of other TAVI-related complications

    at immediate, 30 days, 1 year and annually up to 5 years post implantation

  • +4 more secondary outcomes

Study Arms (1)

single arm, treatment group

Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System

Device: VitaFlow™ Transcatheter Aortic Valve System

Interventions

VitaFlow™ Transcatheter Aortic Valve SystemDEVICE

VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set

single arm, treatment group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team

You may qualify if:

  • Age≥70 years;
  • Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area\<0.8cm² (or EOA index\<0.5cm²/m²);
  • The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
  • 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.

You may not qualify if:

  • Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
  • Vascular diseases or anatomical condition preventing the device access；
  • Previous implantation of mechanical or bioprosthesis valve in the aortic position；
  • Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
  • Ongoing sepsis, including active endocarditis；
  • Estimated Life expectancy\< 12 months；
  • Participating in another trial and the primary endpoint is not achieved.
  • Inability to comply with the clinical investigation follow-up or other requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijing Hospital，Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Zhujun Cai, PhD

CONTACT

(86)(21)38954600zjcai@micoport.com

Jie Bi

CONTACT

(86)(21)38954600jbi@micoport.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 4, 2020

Study Start

April 26, 2020

Primary Completion

December 1, 2021

Study Completion (Estimated)

December 30, 2027

Last Updated

June 4, 2020

Record last verified: 2020-05

Locations

CN(2)