PERIGON Pivotal Trial (PERIGON)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 1313
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
  • Toronto, Canada, M5G 2C4
    • Toronto General Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Campus
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
• France
  • Bordeaux, France, 33604
    • Hôpital Cardiologique Du Haut-Lévêque
  • Paris, France, 75018
    • Hôpital Bichat - Claude Bernard
• Germany
  • Frankfurt, Germany, 60590
    • Universitäts Klinikum Frankfurt - Goethe-Universität
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Köln
    • Cologne, Köln, Germany, 50924
      • Uniklinik Koln
  • München
    • Munich, München, Germany, DE 80636
      • Deutsches Herzzentrum München
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele - Milano
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum (LUMC)
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus MC
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital - Universitätsspital Bern
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
• United States
  • California
    • Los Angeles, California, United States, 90033-5313
      • University of Southern California (USC) University Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045-2545
      • University of Colorado Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Shands
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5853
      • University of Michigan Cardiovascular Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407-1139
      • Minneapolis Heart Institute Foundation
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • New York, New York, United States, 10029
      • The Mount Sinai Medical Center
    • New York, New York, United States, 10032
      • New York-Presbyterian Hospital/Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital (OhioHealth)
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • Oklahoma Heart Hospital
  • Texas
    • Austin, Texas, United States, 78756-4080
      • Cardiothoracic and Vascular Surgeons (CTVS)
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Washington
    • Seattle, Washington, United States, 98195-0001
      • University of Washington Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215-4330
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. 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

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 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Model 400 aortic valve bioprosthesis	Device: Model 400 aortic valve bioprosthesis

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Surgery
• Collaborators: Medtronic
• Investigators: Principal Investigator: Joseph Sabik, MD, University Hospital Cleveland Medical Center (Not a recruiting site); Principal Investigator: Prof. Dr. Robert Johannes Menno Klautz, MD, Leiden University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2014
• Primary Completion (Actual): April 17, 2023
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimated): March 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: PERIGON