Clinical trial NCT03788590: Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
Official title: A Prospective, Multicenter, Single-armed Trial That Aims to Evaluate the Safety and Efficacy of Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Aortic Stenosis
Aortic Regurgitation
Lead sponsor: Ningbo Jenscare Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-27
Enrollment: 133
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.

Detailed description: Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk.

This project take the incidence of all-cause mortality at 12 months since TAVI as the primary endpoint to evaluate the safety and efficacy, then take the procedure success rate, device success rate, incidence of severe adverse events, device operative performance, prosthetic valve performance and quality of life to evaluate transcatheter artificial aortic valve and transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co., Ltd. in clinical application.

Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 65 years of age;
* Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s, or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of \<1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular systolic dysfunction (LVEF\<50%);
* Symptoms suggestive of aortic stenosis, NYHA class III or IV;
* Patients who are considered unsuitable for surgery are considered by two or more than two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system estimation; or there is a severe and irreversible organ damage to the patient, such as lung disease, liver disease, kidney disease and so on; or the patient's physical weakness can not be tolerated by surgery; or have other factors affecting surgery, such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe calcification of the aorta, etc);
* A life expectancy of \> 1 year;
* Voluntarily participate in and sign the informed consent form and willing to undergo the related examination and clinical follow-up.

Exclusion Criteria:

* Untreated severe coronary stenosis and needs revascularization; or acute myocardial infarction occurred within 1 months, or coronary stent implantation in 1 month;
* Artificial heart valve and artificial valve ring have been implanted；
* Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area\<1.5 cm2)；
* left ventricular or atrial thrombus;
* Aortic annulus diameter \<17mm or \>27 mm;
* Severe left ventricular dysfunction, ejection fraction \<20%；
* Severe pulmonary hypertension or severe right ventricular dysfunction；
* The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm;
* Cerebrovascular event in last 3 months；
* Active endocarditis or other active infection;
* Severe renal failure and requires long-term dialysis treatment；
* Severe liver dysfunction；
* Active peptic ulcer；
* Severe coagulation dysfunction; it is known that all anticoagulant schemes are taboo or allergic, or anticoagulants can not be used in the process of testing；
* Severe respiratory failure；
* Severe Alzheimer's disease；
* Patients who were enrolled in any other study in one month;
* Other cases which the researchers believe that it is not suitable to participate in.

Primary outcomes:
measure: All-cause mortality
timeFrame: 12 month
Secondary outcomes:
measure: Procedure success rate
timeFrame: During the TAVI procedure
measure: Device success rate
timeFrame: During the TAVI procedure
measure: Incidence of severe adverse events
timeFrame: During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI
measure: Assessment of device operative performance
timeFrame: During the TAVI procedure
measure: Echocardiographic assessment of valve performance
timeFrame: 30 days, 3 months, 6 months, 12 months after TAVI
measure: Echocardiographic assessment of valve performance
timeFrame: 30 days, 3 months, 6 months, 12 months after TAVI
measure: Evaluation and improvement of quality of life
timeFrame: Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI
measure: Echocardiographic assessment of valve performance
timeFrame: 30 days, 3 months, 6 months, 12 months after TAVI
measure: Echocardiographic assessment of valve performance
timeFrame: 30 days, 3 months, 6 months, 12 months after TAVI
measure: Echocardiographic assessment of valve performance
timeFrame: 30 days, 3 months, 6 months, 12 months after TAVI
Other outcomes:
Locations:
Study officials:
affiliation: Ningbo Jenscare Biotechnology Co., Ltd.
name: Peng Cao, Doctor
role: STUDY_DIRECTOR
References: