PERIGON Pivotal Trial

Running, not enrolling · Not applicable

Conditions studied: Aortic Stenosis

In brief

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Key facts

Study ID

NCT02088554

Run by

Medtronic Cardiac Surgery

People needed

1312

Starts

2014-05-12

Expected to finish

2035-12-31

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (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

You may not qualify if…

• 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 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 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 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

Where it is running

• University of Southern California (USC) University Hospital — Los Angeles, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• University of Florida Shands — Gainesville, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Cardiovascular Center — Ann Arbor, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• The Mount Sinai Medical Center — New York, New York, United States
• New York-Presbyterian Hospital/Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Riverside Methodist Hospital (OhioHealth) — Columbus, Ohio, United States
• ProMedica Toledo Hospital — Toledo, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Cardiothoracic and Vascular Surgeons (CTVS) — Austin, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Aurora Saint Luke's Medical Center — Milwaukee, Wisconsin, United States
• London Health Sciences Centre - University Campus — London, Ontario, Canada
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) — Québec, Canada
• Toronto General Hospital — Toronto, Canada

Full record on ClinicalTrials.gov

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