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

NCT03025971 | Completed

• 1 other identifier: S20131216
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Aortic Valve Disease

Keywords

Severe Aortic Stenosis and/or severe aortic regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  12 months

Secondary Outcomes (1)

• Cardiac function improvement

  30 days, 6 months, 12 months and annually up to 5 years

Other Outcomes (4)

• Incidence of Major Adverse Cardiovascular Cerebrovascular Events (MACCE)

  30 days, 6 months, 12 months and annually up to 5 years

• Incidence of Major Adverse Valve Related Events (MAVRE)

  30 days, 6 months, 12 months and annually up to 5 years

• Technical Success

  Within 30 days post procedure

Study Arms (1)

Single arm observational study

OTHER

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.

Device: J-Valve Transcatheter Aortic valve replacement

Interventions

J-Valve Transcatheter Aortic valve replacement DEVICE

Transapical Transcatheter Aortic Valve Replacement

Also known as: TAVI

Single arm observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• JC Medical, Inc., an affiliate of Edwards Lifesciences LLC: lead

Study Sites (3)

West China Hospital

Chengdu, China

Location

Zhongshan Hospital

Shanghai, China

Location

Fuwai Cardiovascular Hospital

Yunnan, China

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ji Zhang, MD

  CEO, President

  STUDY DIRECTOR

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: January 12, 2017
• First Posted: January 20, 2017
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (3)