Clinical trial NCT02088554: PERIGON Pivotal Trial
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2014-03-17
Enrollment: 1312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
timeFrame: 1 year post-implant
measure: 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
timeFrame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
timeFrame: Discharge (up to 30 days), 3-6 months, 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
timeFrame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
timeFrame: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
timeFrame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
timeFrame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
timeFrame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
timeFrame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Secondary outcomes:
measure: Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant
timeFrame: Annually, at years 2, 3, 4, and 5 post-implant
Other outcomes:
measure: Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 1 year post-implant
measure: 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 (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months, 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
timeFrame: 3-6 months, and 1 year post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve by Clinically Acceptable Hemodynamic Performance From Years 6 Through 12 Post-implant.
timeFrame: Annually, years 6-12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From Valve-related Death
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From All-cause Mortality
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Change in NYHA Functional Classification Status From Baseline
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 12 Years Post-procedure
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 12 Years Post-implant
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) up to 12 Years Post-implant
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 12 Years Post-implant
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 12 Years Post-implant
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 12 Years Post-implant
timeFrame: Annually, years 6 though 12 post-implant
measure: Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 12 Years Post-implant
timeFrame: Annually, years 6 though 12 post-implant
Locations:
city: Los Angeles
country: United States
facility: University of Southern California (USC) University Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Shands
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Cardiovascular Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital (OhioHealth)
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons (CTVS)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Bordeaux
country: France
facility: Hôpital Cardiologique du Haut-Lévêque
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Cologne
country: Germany
facility: Uniklinik Köln
state: Köln
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: München
city: Frankfurt
country: Germany
facility: Universitäts Klinikum Frankfurt - Goethe-Universität
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Milano
country: Italy
facility: Ospedale San Raffaele - Milano
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
Study officials:
affiliation: University Hospital Cleveland Medical Center (Not a recruiting site)
name: Joseph Sabik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center
name: Prof. Dr. Robert Johannes Menno Klautz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, Moront M, Misfeld M, Zeng C, Sabik Iii JF; PERIGON Investigators. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):425-431. doi: 10.1093/ejcts/ezx066.