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

JC Medical, Inc.3 sites in 1 country107 target enrollmentMarch 2014

ConditionsAortic Valve Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Disease
Sponsor: JC Medical, Inc.
Enrollment: 107
Locations: 3
Primary Endpoint: All-cause Mortality
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

April 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

JC Medical, Inc.

Responsible Party

Sponsor

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;

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