Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System

NCT ID: NCT03788590

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-23
• Study Completion Date: 2021-12-30

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.

Conditions

Severe Aortic Stenosis; Aortic Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jenscare TAVI

Patients undergoing a Jenscare TAVI and delivery system

Group Type: EXPERIMENTAL

Jenscare TAVI

Intervention Type: DEVICE

Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.

Interventions

Jenscare TAVI

Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Jenscare Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peng Cao, Doctor

Role: STUDY_DIRECTOR

Ningbo Jenscare Biotechnology Co., Ltd.

Central Contacts

Xiaolin Wang, Master

Role: CONTACT

Alice.w@linksmed.cn

8617717875521 ext. 057463935666

Zhigang Song, Proferssor

Role: CONTACT

zhgsong@smmu.edu.cn

8613917856919 ext. 057463935666

Other Identifiers

LT-2017-01

Identifier Type: -

Identifier Source: org_study_id