PERIGON Pivotal Trial

N/AActive Not RecruitingNCT02088554

Medtronic Cardiac Surgery1,312 enrolled

Overview

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

This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects were to be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial includes male and female patients of legal age to provide informed consent in the country where they enrolled in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects are followed out to 5 years, and select sites follow subjects out to 12 years. Enrollment closed on 14Jul2017 for all valve sizes. Enrollment was reopened in Apr2019 for the 29mm valve size at a subset of US and Canadian sites to obtain greater patient numbers required by the FDA to support US commercial approval of this valve size. Enrollment for the 29mm valve size closed on 14Feb2023.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,312

Conditions

Aortic Stenosis

Interventions

Model 400 aortic valve bioprosthesisDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Patient is geographically stable and willing to return to the implanting site for all follow-up visits 3. Patient is of legal age to provide informed consent in the country where they enroll in the trial 4. 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: 1. 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 2. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis 3. Patient presents with active endocarditis, active myocarditis or other systemic infection 4. 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) 5. 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 6. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)\<30 mL/min/1.73 m2 7. Patient has hyperparathyroidism 8. Patient is participating in another investigational device or drug trial or observational competitive study 9. Patient is pregnant, lactating or planning to become pregnant during the trial period 10. Patient has a documented history of substance (drug or alcohol) abuse 11. Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography 12. Patient has systolic ejection fraction (EF)\<20% as assessed by echocardiography 13. Patient has Grade IV Diastolic Dysfunction 14. Patient has documented bleeding diatheses 15. Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment 16. Patient requires emergency surgery

Locations (38)

Outcomes

Primary Outcomes

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant

Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are 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 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.

Time frame: 1 year post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year

At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure

A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.

Time frame: Discharge (up to 30 days), 3-6 months, 1 year post-implant

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 28 more locations

Secondary Outcomes

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant

Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.