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Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation

Primary Purpose

Aortic Valve Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
J-Valve Transcatheter Aortic valve replacement
Sponsored by
JC Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease focused on measuring Severe Aortic Stenosis and/or severe aortic regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed Informed Consent
  2. Age ≥18years of age
  3. Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA rating of NYHA ≥ II
  4. Has undergone the diagnosis of at least one interventional cardiologist and two cardiac surgeons: the patients are contraindicated for traditional open heart valve replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible complications, or other influential post-operative factors [such as severe calcification in the ascending aorta and aortic valve, weak physical condition, chest deformities, severe liver diseases, severe lung diseases, etc.] or high risk for surgery (LogEuroSCORE≥20% and or STS≥8)
  5. Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons that the patient may benefit from a valve implantation
  6. Severe aortic stenosis with electrocardiography results as follows: mean transvalvular pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s, aortic valve area < 0.8 cm2 (or AVA index < 0.5 cm2/m2); and/or severe aortic regurgitation, electrocardiography results show symptomatic moderate regurgitation or severe regurgitation
  7. Without severe pulmonary arterial hypertension
  8. The patient is willing to cooperate with all follow-up visits.

    Anatomical Inclusion Criteria:

  9. Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements;
  10. Ascending aortic diameter <50mm at the sinotubular junction.

Exclusion Criteria:

  1. Patients with infection or who have any sign of infection
  2. Previous history of endocarditis or patients with active endocarditis
  3. Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non Q-wave MI with creatine kinase, an increase in troponin T)
  4. Any cardiac mass discovered during echocardiography, left ventricular or atrial thrombosis
  5. Suffering from uncontrollable atrial fibrillation
  6. Hereditary hypertrophic cardiomyopathy
  7. Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater)
  8. Has previously undergone aortic valve implantation (mechanical valve or biological valve frame)
  9. Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications, nitinol or porcine products
  10. Is known to be contraindicated for or is allergic to all anti-coagulants or is unable to use anti-coagulants during the study
  11. Is known to have one of the following conditions (according to evaluations beginning from screening through the day of the procedure):

    • Other diseases that may reduce the life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.)
    • Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.)
    • Plans to undergo surgery that may result in non-compliance with the study protocol or that may cause confusion in data interpretation.
  12. Has experienced a cerebrovascular accident (CVA) within the last 6 months
  13. Patients suffering from stenosis of the carotid, internal carotid, or vertebral arteries (70%)
  14. White cell count <3×109/L, platelet count<50×109/L
  15. Hemoglobin <90 g/L
  16. Severely lowered left ventricular function, left ventricular ejection fraction < 20 %
  17. Aortic aneurysm in the abdomen or chest
  18. Hepatic encephalopathy or acute active hepatitis
  19. Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L)
  20. Prone to bleeding, has a history of clotting disorders or refuses blood transfusions
  21. Active ulcer or active gastrointestinal (GI) bleeding
  22. Suffering from nervous system diseases that severely influence the patients' ability to move or to perform daily activities
  23. Patients with severe dementia
  24. Any reason for emergent surgery
  25. Taking part in other clinical trials for pharmaceuticals or medical devices
  26. Those who are pregnant, plan to become pregnant, or who are taking estrogen or estrogen-like drugs (women suspected of being pregnant must test negative on a urine pregnancy test or for chorionic gonadotropin serum).

    -

Sites / Locations

  • West China Hospital
  • Zhongshan Hospital
  • Fuwai Cardiovascular Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm observational study

Arm Description

Intervention: J-Valve Transcatheter Aortic valve replacement. Prospective, multi-center, single arm observational study. Subjects will include patients with severe aortic valve stenosis and/or severe aortic regurgitation who require replacement of their native aortic valve.

Outcomes

Primary Outcome Measures

All-cause Mortality

Secondary Outcome Measures

Cardiac function improvement
New York Heart Association (NYHA) Functional class

Full Information

First Posted
January 12, 2017
Last Updated
May 1, 2023
Sponsor
JC Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03025971
Brief Title
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
Official Title
Efficacy and Safety Evaluation for The Interventional Aortic Valve Bioprosthesis and Delivery System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation With Elevated Surgical Risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JC Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective, multicenter, nonrandomized, single-arm, clinical study.
Detailed Description
To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
Severe Aortic Stenosis and/or severe aortic regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm observational study
Arm Type
Other
Arm Description
Intervention: J-Valve Transcatheter Aortic valve replacement. Prospective, multi-center, single arm observational study. Subjects will include patients with severe aortic valve stenosis and/or severe aortic regurgitation who require replacement of their native aortic valve.
Intervention Type
Device
Intervention Name(s)
J-Valve Transcatheter Aortic valve replacement
Other Intervention Name(s)
TAVI
Intervention Description
Transapical Transcatheter Aortic Valve Replacement
Primary Outcome Measure Information:
Title
All-cause Mortality
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiac function improvement
Description
New York Heart Association (NYHA) Functional class
Time Frame
30 days, 6 months, 12 months and annually up to 5 years
Other Pre-specified Outcome Measures:
Title
Incidence of Major Adverse Cardiovascular Cerebrovascular Events (MACCE)
Description
All-cause mortality, myocardial infarction (Q-wave and non Q-wave), stroke, acute renal damage, major vascular complications, life-threatening bleeding events, or re-operation due to valvular dysfunction (surgical or interventional treatment).
Time Frame
30 days, 6 months, 12 months and annually up to 5 years
Title
Incidence of Major Adverse Valve Related Events (MAVRE)
Description
Valve related deaths, valve related complications, or implantation of a permanent pacemaker or defibrillator within 14 days of operation. Valve related complications include any structural degradation or non-structural dysfunction of the valve prosthesis, thrombosis, embolism, bleeding events, or valve prosthesis endocarditis.
Time Frame
30 days, 6 months, 12 months and annually up to 5 years
Title
Technical Success
Description
Implantation of the valve into the precise anatomical position of the native aortic valve. No valve migration No positioning errors. Paravalvular leak is less than moderate (ratio of regurgitation surface area/left ventricular surface area 25-50%). Successful removal of the entire delivery device. Implantation of the valve into the precise anatomical position of the native aortic valve. No valve migration No positioning errors. Paravalvular leak is less than moderate (ratio of regurgitation surface area/left ventricular surface area 25-50%). Successful removal of the entire delivery device.
Time Frame
Within 30 days post procedure
Title
Device Success
Description
no intraoperative death, valve prosthesis has been accurately implanted into the anatomic position of the native aortic valve is performing its anticipated function. The intended performance of the bioprosthetic valve function: no mismatch between the valve prosthesis and the patient, mean transvalvular pressure gradient is ≤20 mmHg or peak forward aortic blood flow velocity of <3.0 m/s, and no moderate or severe aortic regurgitation
Time Frame
Within 30 days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Age ≥18years of age Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA rating of NYHA ≥ II Has undergone the diagnosis of at least one interventional cardiologist and two cardiac surgeons: the patients are contraindicated for traditional open heart valve replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible complications, or other influential post-operative factors [such as severe calcification in the ascending aorta and aortic valve, weak physical condition, chest deformities, severe liver diseases, severe lung diseases, etc.] or high risk for surgery (LogEuroSCORE≥20% and or STS≥8) Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons that the patient may benefit from a valve implantation Severe aortic stenosis with electrocardiography results as follows: mean transvalvular pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s, aortic valve area < 0.8 cm2 (or AVA index < 0.5 cm2/m2); and/or severe aortic regurgitation, electrocardiography results show symptomatic moderate regurgitation or severe regurgitation Without severe pulmonary arterial hypertension The patient is willing to cooperate with all follow-up visits. Anatomical Inclusion Criteria: Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements; Ascending aortic diameter <50mm at the sinotubular junction. Exclusion Criteria: Patients with infection or who have any sign of infection Previous history of endocarditis or patients with active endocarditis Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non Q-wave MI with creatine kinase, an increase in troponin T) Any cardiac mass discovered during echocardiography, left ventricular or atrial thrombosis Suffering from uncontrollable atrial fibrillation Hereditary hypertrophic cardiomyopathy Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater) Has previously undergone aortic valve implantation (mechanical valve or biological valve frame) Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications, nitinol or porcine products Is known to be contraindicated for or is allergic to all anti-coagulants or is unable to use anti-coagulants during the study Is known to have one of the following conditions (according to evaluations beginning from screening through the day of the procedure): Other diseases that may reduce the life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.) Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.) Plans to undergo surgery that may result in non-compliance with the study protocol or that may cause confusion in data interpretation. Has experienced a cerebrovascular accident (CVA) within the last 6 months Patients suffering from stenosis of the carotid, internal carotid, or vertebral arteries (70%) White cell count <3×109/L, platelet count<50×109/L Hemoglobin <90 g/L Severely lowered left ventricular function, left ventricular ejection fraction < 20 % Aortic aneurysm in the abdomen or chest Hepatic encephalopathy or acute active hepatitis Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L) Prone to bleeding, has a history of clotting disorders or refuses blood transfusions Active ulcer or active gastrointestinal (GI) bleeding Suffering from nervous system diseases that severely influence the patients' ability to move or to perform daily activities Patients with severe dementia Any reason for emergent surgery Taking part in other clinical trials for pharmaceuticals or medical devices Those who are pregnant, plan to become pregnant, or who are taking estrogen or estrogen-like drugs (women suspected of being pregnant must test negative on a urine pregnancy test or for chorionic gonadotropin serum). -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Zhang, MD
Organizational Affiliation
CEO, President
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital
City
Chengdu
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Facility Name
Fuwai Cardiovascular Hospital
City
Yunnan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation

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