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

Aortic Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025971
• Other study ID #: S20131216
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2020

Study information

• Verified date: May 2023
• Source: JC Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 2020
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? 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). -

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• J-Valve Transcatheter Aortic valve replacement
Transapical Transcatheter Aortic Valve Replacement

Locations

Country	Name	City	State
China	West China Hospital	Chengdu
China	Zhongshan Hospital	Shanghai
China	Fuwai Cardiovascular Hospital	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
JC Medical, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Major Adverse Cardiovascular Cerebrovascular Events (MACCE)	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).	30 days, 6 months, 12 months and annually up to 5 years
Other	Incidence of Major Adverse Valve Related Events (MAVRE)	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.	30 days, 6 months, 12 months and annually up to 5 years
Other	Technical Success	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.	Within 30 days post procedure
Other	Device Success	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	Within 30 days post procedure
Primary	All-cause Mortality		12 months
Secondary	Cardiac function improvement	New York Heart Association (NYHA) Functional class	30 days, 6 months, 12 months and annually up to 5 years