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

NCT03788590 | Unknown

• 1 other identifier: LT-2017-01
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Aortic Stenosis; Aortic Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Cumulative incidence of a combination of all cause death at 12 month after TAVI

  12 month

Secondary Outcomes (10)

• Procedure success rate

  During the TAVI procedure

• Device success rate

  During the TAVI procedure

• Incidence of severe adverse events

  During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI

• Assessment of device operative performance

  During the TAVI procedure

• Echocardiographic assessment of valve performance

  30 days, 3 months, 6 months, 12 months after TAVI

Study Arms (1)

Jenscare TAVI

EXPERIMENTAL

Patients undergoing a Jenscare TAVI and delivery system

Device: Jenscare TAVI

Interventions

Jenscare TAVI 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.

Jenscare TAVI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Ningbo Jenscare Biotechnology Co., Ltd.: lead

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Peng Cao, Doctor

  Ningbo Jenscare Biotechnology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Xiaolin Wang, Master

CONTACT

8617717875521; Alice.w@linksmed.cn

Zhigang Song, Proferssor

CONTACT

8613917856919; zhgsong@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 27, 2018
• Study Start: February 23, 2019
• Primary Completion: November 23, 2021
• Study Completion: December 30, 2021
• Last Updated: January 8, 2019

Record last verified: 2018-12