Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System (TAVI)

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

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Regurgitation; Severe Aortic Stenosis
• Intervention / Treatment: Device: Jenscare TAVI

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.

• Study Type: Interventional
• Enrollment (Anticipated): 133
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jenscare TAVI; Patients undergoing a Jenscare TAVI and delivery system	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Cumulative incidence of a combination of all cause death at 12 month after TAVI	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success rate	Documentation of no death occurred during or within 72 hours after TAVI, no conversion to conventional cardiopulmonary bypass, the value was placed in the correct anatomical position and achieve the desired effect	During the TAVI procedure
Device success rate	Documentation of the device was implanted successfully, placed in the correct anatomical position and achieve the desired effect	During the TAVI procedure
Incidence of severe adverse events	Documentation of the serious long-term complications, including mortality, stroke, transient ischemic stroke, myocardial infarction, dialysis and reinterventions	During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI
Assessment of device operative performance	Using the following measure (loading and releasing properties of artificial aortic valve; pushing, emptying, withdrawing, developing performance, fracture of the delivery system) that can be converted to utilities using an algorithm. Utilities range from 1 to 3, with 3 representing perfect performance, and 1 corresponding to the worst performance state.	During the TAVI procedure
Echocardiographic assessment of valve performance	Using the following measures: effective orifice area (EOA)	30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance	Using the following measures: transvalvular mean gradient	30 days, 3 months, 6 months, 12 months after TAVI
Evaluation and improvement of quality of life	Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.	Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance	Using the following measures: peak flow velocity	30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance	Using the following measures: degree of aortic valve regurgitation	30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance	Using the following measures: degree of perivalvular leakage	30 days, 3 months, 6 months, 12 months after TAVI

Collaborators and Investigators

• Sponsor: Ningbo Jenscare Biotechnology Co., Ltd.
• Investigators: Study Director: Peng Cao, Doctor, Ningbo Jenscare Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 23, 2019
• Primary Completion (Anticipated): November 23, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 25, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 5, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: LT-2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No