NCT04414878

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 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 Progress92%
Jan 2018Jan 2027

Study Start

First participant enrolled

January 31, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

May 27, 2020

Last Update Submit

May 31, 2020

Conditions

Aortic 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 (10)

  • Valve function-mean prosthetic valve gradient

    at 30 days, 6 months, and 1 year post implantation

  • Valve function- effective orifice area

    at 30 days, 6 months, and 1 year post implantation

  • Valve function- degree of prosthetic valve regurgitation

    at 30 days, 6 months, and 1 year post implantation

  • Rate of safety events according to VARC2

    at 30 days, 6 months, 1 year and annually up to 5 years post implantation

  • Rate of other TAVI-related complications

    at 30 days, 6 months, 1 year and annually up to 5 years post implantation

  • +5 more secondary outcomes

Study Arms (1)

Single arm clinical investigation

EXPERIMENTAL

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

Device: VitaFlow™ II Transcatheter Aortic Valve System

Interventions

VitaFlow™ II Transcatheter Aortic Valve SystemDEVICE

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

Single arm clinical investigation

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age≥70 years;
  • 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);
  • NYHA≥II class;
  • Estimated life-expectancy\>12 months after implantation of the prosthetic valve;
  • Anatomically suitable for the transcatheter aortic valve implantation procedure;
  • 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.

You may not qualify if:

  • Acute myocardial infarction (MI) in last 30 days before the treatment;
  • Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
  • Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
  • Previous implantation of heart valve at any position；
  • Hemodynamic instability requiring mechanical hemodynamic support devices;
  • Need for emergency surgery for any reason;
  • Hypertrophic cardiomyopathy with obstruction;
  • Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%;Severe right ventricular dysfunction;
  • Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
  • Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
  • Congenital aortic valve stenosis or unicuspid aortic valve;
  • Vascular diseases or anatomical condition preventing the device access;
  • Active endocarditis or other active infections at the time of treatment;
  • 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 (4)

Fuwai Hospital

Beijing, Beijing Municipality, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Bi Jie

CONTACT

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

Zhujun Cai, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 4, 2020

Study Start

January 31, 2018

Primary Completion

January 31, 2022

Study Completion (Estimated)

January 31, 2027

Last Updated

June 4, 2020

Record last verified: 2020-05

Locations

CN(4)