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

JC Medical

Status: Completed

Conditions: Aortic Valve Disease

Treatments: Device: J-Valve Transcatheter Aortic valve replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT03025971

S20131216

Details and patient eligibility

About

A prospective, multicenter, nonrandomized, single-arm, clinical study.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Single arm observational study

Other group

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.

Treatment:

Device: J-Valve Transcatheter Aortic valve replacement