PERIGON Pivotal Trial (PERIGON)
Aortic Stenosis
About this trial
This is an interventional treatment trial for Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
Patient has moderate or greater 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:
i. LAA ligation ii. CABG iii. PFO closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. 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 in the country where they enroll in the trial
- 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
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 Model 400 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 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 during the trial period
- 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 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
Sites / Locations
- University of Southern California (USC) University Hospital
- University of Colorado Hospital
- Hartford Hospital
- University of Florida Shands
- Piedmont Hospital
- University of Maryland Medical Center
- Massachusetts General Hospital
- University of Michigan Cardiovascular Center
- Minneapolis Heart Institute Foundation
- Maimonides Medical Center
- The Mount Sinai Medical Center
- New York-Presbyterian Hospital/Columbia University Medical Center
- Cleveland Clinic
- Riverside Methodist Hospital (OhioHealth)
- ProMedica Toledo Hospital
- Oklahoma Heart Hospital
- Cardiothoracic and Vascular Surgeons (CTVS)
- Houston Methodist Hospital
- University of Washington Medical Center
- Aurora Saint Luke's Medical Center
- London Health Sciences Centre - University Campus
- University of Ottawa Heart Institute
- Montreal Heart Institute
- Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
- Toronto General Hospital
- Hôpital Cardiologique du Haut-Lévêque
- Hôpital Bichat - Claude Bernard
- Uniklinik Köln
- Deutsches Herzzentrum München
- Universitäts Klinikum Frankfurt - Goethe-Universität
- Medizinische Hochschule Hannover
- Herzzentrum Leipzig GmbH
- Ospedale San Raffaele - Milano
- Leids Universitair Medisch Centrum (LUMC)
- Erasmus MC
- Inselspital - Universitätsspital Bern
- UniversitätsSpital Zürich
- Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
Arms of the Study
Arm 1
Experimental
Model 400 aortic valve bioprosthesis