VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

M

MicroPort

Status

Enrolling

Conditions

Aortic Stenosis

Treatments

Device: VitaFlow™ II Transcatheter Aortic Valve System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04414878
SUPERIOR-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

145 participants in 1 patient group

Single arm clinical investigation
Experimental group
Description:
Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System
Treatment:
Device: VitaFlow™ II Transcatheter Aortic Valve System

Trial contacts and locations

4

Loading...

Central trial contact

Zhujun Cai, PhD; Bi Jie

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems