Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement

Venus MedTech (HangZhou) Inc.1 site in 1 country80 target enrollmentSeptember 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Venus MedTech (HangZhou) Inc.
Enrollment: 80
Locations: 1
Primary Endpoint: All cause mortality and major stroke at 12 months post-procedure.
Last Updated: 11 years ago

objectives
- Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery
- Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Continuous observe 12 months of safety and efficacy.
Approximately 80 patients presenting with native aortic valve stenosis necessitating valve replacement which are considered unsuitable for Surgical Valve Replacement, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
Safety and performance will be evaluated at discharge and at 30 days post procedure. Valve safety, performance and placement will be followed up at 6 and 12 months post-procedure.

A prospective OPC study to evaluate its performance and long-term safety and effectiveness of Venus-A aortic valve.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

April 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mm Hg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2)
•Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II
•The subject or the subject's legal representative was informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
•The subject agreed to comply follow-up evaluation
•is evaluated by at least one cardiologist and two cardiovascular surgeon, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
•STS score ≥ 10%

•Patient refuses aortic valve replacement surgery.
•Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment \[defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
•Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
•Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
•Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days （6 month if DES implant）
•Implanted any heart valve prosthesis, prosthetic valve ring, severe mitral valve ring calcification (MAC), severe（\>3＋）mitral valve insufficiency, or Gorelin symptom
•Blood dyscrasia such as leukopenia (WBC \< 3×109/L), acute anemia (Hgb \< 90 g/L), thrombocytopenia (PLT \< 50×109/L), bleeding diathesis, or history of coagulopathy.
•Untreated clinically significant coronary artery disease requiring revascularization
•Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
•Need for emergency surgery for any reason