PERIGON Pivotal Trial

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Detailed Description
-----------------
This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects will be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial will include male and female patients of legal age to provide informed consent in the country where they enroll in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects will be followed out to 5 years and select sites will follow subjects out to 12 years. Enrollment is closed as of 14Feb2023.

Official Title
-----------------
Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Device: Model 400 aortic valve bioprosthesis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Model 400 aortic valve bioprosthesis<br> | Device: Model 400 aortic valve bioprosthesis<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death. | Safety of the valve will be evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events will be evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. | A minimum of 15 subjects per valve size will be following through one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance. | The effectiveness endpoints are: New York Heart Association Functional Classification (at discharge (or 30 days), 3-6 months, 1 year and annually thereafter through 5 years) as compared to Baseline. Clinically acceptable Hemodynamic Performance (at discharge (or 30 days), 3-6 months, 1 year and annually thereafter through 5 years) confirmed by core lab evaluation of echocardiography. | A minimum of 15 subjects per valve size will be following through one year |