Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis

Shanghai MicroPort Medical (Group) Co., Ltd.1 site in 1 country89 target enrollmentSeptember 2014

ConditionsAortic Valve Disease Aortic Valve Stenosis Aortic Valve Calcification

Overview

Phase: N/A
Intervention: Not specified
Conditions: Aortic Valve Disease
Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Enrollment: 89
Locations: 1
Primary Endpoint: All cause mortality or major stroke at 12 months.
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.

Detailed Description

1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery. 2. The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients are recruited in the study with native aortic valve stenosis which are considered unsuitable for Surgical Valve Replacement.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

September 2021

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years or older, male or non pregnant women;
•Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of \< 1.0 cm2 (or AVA index \< 0.6 cm2/m2)
•Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart Association) Functional Class ≥ II
•Expectation of life\>12 months
•Calcific aortic stenosis, which is suitable for transcatheter aortic valve implantation anatomically
•is evaluated by at least two cardiovascular physicians, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
•The subject agreed to comply follow-up evaluation

Exclusion Criteria

•Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
•aortic valve is a congenital unicuspid valve, or is non-calcified.
•Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days
•Implanted any heart valve prosthesis, prosthetic valve ring, severe（\>3＋）mitral valve insufficiency
•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 mechanical cardiac assist or mechanical hemodynamic support devices
•Need for emergency surgery for any reason
•Hypertrophic cardiomyopathy with or without obstruction
•Severe ventricular dysfunction with LVEF (Left ventricular ejection fraction) \< 20%

Outcomes

Primary Outcomes

All cause mortality or major stroke at 12 months.

Time Frame: 12 months

Secondary Outcomes

The improvement of heart function(30 days, 3, 6 and 12 months)
MACCE(major adverse cardiovascular and cerebrovascular events)(30 days, 3, 6 and 12 months)
Device success(7 days post-operation)
Valve performance(30 days, 3, 6 and 12 months)