Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788590
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ningbo Jenscare Biotechnology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Severe Aortic Stenosis Aortic Regurgitation Device: Jenscare TAVI Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 133 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 23, 2019
Estimated Primary Completion Date : November 23, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 12 month ]
    Cumulative incidence of a combination of all cause death at 12 month after TAVI


Secondary Outcome Measures :
  1. Procedure success rate [ Time Frame: During the TAVI procedure ]
    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

  2. Device success rate [ Time Frame: During the TAVI procedure ]
    Documentation of the device was implanted successfully, placed in the correct anatomical position and achieve the desired effect

  3. Incidence of severe adverse events [ Time Frame: During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI ]
    Documentation of the serious long-term complications, including mortality, stroke, transient ischemic stroke, myocardial infarction, dialysis and reinterventions

  4. Assessment of device operative performance [ Time Frame: During the TAVI procedure ]
    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.

  5. Echocardiographic assessment of valve performance [ Time Frame: 30 days, 3 months, 6 months, 12 months after TAVI ]
    Using the following measures: effective orifice area (EOA)

  6. Echocardiographic assessment of valve performance [ Time Frame: 30 days, 3 months, 6 months, 12 months after TAVI ]
    Using the following measures: transvalvular mean gradient

  7. Evaluation and improvement of quality of life [ Time Frame: Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI ]
    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.

  8. Echocardiographic assessment of valve performance [ Time Frame: 30 days, 3 months, 6 months, 12 months after TAVI ]
    Using the following measures: peak flow velocity

  9. Echocardiographic assessment of valve performance [ Time Frame: 30 days, 3 months, 6 months, 12 months after TAVI ]
    Using the following measures: degree of aortic valve regurgitation

  10. Echocardiographic assessment of valve performance [ Time Frame: 30 days, 3 months, 6 months, 12 months after TAVI ]
    Using the following measures: degree of perivalvular leakage



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788590


Contacts
Layout table for location contacts
Contact: Xiaolin Wang, Master 8617717875521 ext 057463935666 Alice.w@linksmed.cn
Contact: Zhigang Song, Proferssor 8613917856919 ext 057463935666 zhgsong@smmu.edu.cn

Sponsors and Collaborators
Ningbo Jenscare Biotechnology Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Peng Cao, Doctor Ningbo Jenscare Biotechnology Co., Ltd.

Layout table for additonal information
Responsible Party: Ningbo Jenscare Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03788590     History of Changes
Other Study ID Numbers: LT-2017-01
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction