PERIGON Japan Trial

This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.

This clinical trial information was submitted voluntarily under the applicable law and therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act of 42 CRF 11.24 and 11.44.)

Inclusion criteria

• Patient has severe aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:

• Left atrial appendage (LAA) ligation
• Coronary artery bypass graft (CABG)
• Patent foramen ovale (PFO) closure
• Ascending aortic aneurysm or dissection repair not requiring circulatory arrest
• Resection of a sub-aortic membrane not requiring myectomy
• Patient is geographically stable and willing to return to the implanting site for all follow-up visits
• Patient is of legal age to provide informed consent
• Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
• In the opinion of the investigator, pre-operative imaging indicates the patient may be suitable for a 17mm size valve

Exclusion criteria

• Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
• Patient has had previous implant and then explant of the MDT-2215 aortic valve bioprosthesis
• Patient presents with active endocarditis, active myocarditis or other systemic infection
• Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:

• Ascending aortic aneurysm or dissection repair requiring circulatory arrest
• Acute type A aortic dissection
• Ventricular aneurysm
• Porcelain aorta
• Hostile mediastinum
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Documented pulmonary hypertension (systolic >60mmHg)
• Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:

• Child-Pugh Class C liver disease
• Terminal cancer
• End-stage lung disease
• Patient has renal failure, defined as dialysis therapy or glomerular filtration rate (GFR)<30 mL/min/1.73 m2
• Patient has hyperparathyroidism
• Patient is participating in another investigational device or drug trial or observational competitive study
• Patient is pregnant, lactating or planning to become pregnant
• Patient has a documented history of substance (drug or alcohol) abuse
• Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
• Patient has systolic ejection fraction (EF)<20% as assessed by echocardiography
• Patient has grade IV diastolic dysfunction
• Patient has documented bleeding diatheses
• Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment
• Patient requires emergency surgery
• Patient is in NYHA Class I
• Operative Exclusion Criteria:

• 1.) Prior to attempted implant of MDT-2215 valve, it is identified the patient requires a concomitant procedure not allow per the enrollment exclusion criteria
• 2.) Patient anatomy is not suitable for implant of a size 17mm MDT-2215 aortic valve bioprosthesis