A Multicenter, Prospective, Single-Arm, Objective Performance Criteria Study to Evaluate the Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis

Peijia Medical Technology (Suzhou) Co., Ltd.1 site in 1 country120 target enrollmentSeptember 22, 2017

ConditionsAortic Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Stenosis
Sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.
Enrollment: 120
Locations: 1
Primary Endpoint: All-cause mortality at 12 months
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.

Registry

clinicaltrials.gov

Start Date

September 22, 2017

End Date

May 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peijia Medical Technology (Suzhou) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
•Age ≥ 70 years;
•Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ≥ 4.0 m/s, or aortic-valve gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area \< 0.8 cm2, or effective orifice area \< 0.5 cm2/m2);
•Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
•Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) \[13\] \*;
•Life expectancy after implantation of prosthetic valve is more than one year evaluated by the cardiac team (including at least two cardiac surgeons);
•Aortic annulus diameter ≥ 18 mm and ≤ 29 mm (measured by cardiac CT);
•Ascending aorta diameter \< 50 mm
•\*: If the patient meets any of the following criteria judged by a multidisciplinary cardiac team composed of cardiologists and cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two cardiovascular surgeons), the patient will be identified as unsuitable for conventional surgery (at least STS ≥ 8 points):
•Estimated risk of surgery-related death or disability \> 50% within 1 year;

Exclusion Criteria

•Patients with bacteremia or toxemia;
•Previous endocarditis or active endocarditis;
•Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T) within 30 days;
•Any intracardiac mass, left ventricular or atrial thrombus, vegetation on echocardiography;
•Symptomatic atrial fibrillation that cannot be improved by drug therapy;
•Familial hypertrophic cardiomyopathy;
•Mitral or tricuspid valve insufficiency (grade II regurgitation or higher);
•Previous aortic valve graft (mechanical or bioprosthetic valve);
•Known allergies to contrast agents, aspirin, heparin, ticlopidine drugs, nitinol shape memory alloy, or bovine products;
•Known contraindications or allergies to anticoagulant regimens, or inability to use anticoagulants throughout the trial;

Outcomes

Primary Outcomes

All-cause mortality at 12 months

Time Frame: 12 months

All-cause mortality

Secondary Outcomes

Device success rate (Immediate after procedure)(Immediate after procedure)
Procedure success rate(72 hours after procedure/prior to discharge)
Cardiac function improvement(30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years)