PERIGON Pivotal Trial

NCT ID: NCT02088554

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-12
• Study Completion Date: 2035-12-31

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.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Model 400 aortic valve bioprosthesis

Group Type: EXPERIMENTAL

Model 400 aortic valve bioprosthesis

Intervention Type: DEVICE

Interventions

Model 400 aortic valve bioprosthesis

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Sabik, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cleveland Medical Center (Not a recruiting site)

Prof. Dr. Robert Johannes Menno Klautz, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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

Hôpital Cardiologique du Haut-Lévêque

Bordeaux, , France

Hôpital Bichat - Claude Bernard

Paris, , France

Uniklinik Köln

Cologne, Köln, Germany

Deutsches Herzzentrum München

Munich, München, Germany

Universitäts Klinikum Frankfurt - Goethe-Universität

Frankfurt, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Ospedale San Raffaele - Milano

Milan, , Italy

Leids Universitair Medisch Centrum (LUMC)

Leiden, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Inselspital - Universitätsspital Bern

Bern, , Switzerland

UniversitätsSpital Zürich

Zurich, , Switzerland

Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

London, , United Kingdom

Countries

United States; Canada; France; Germany; Italy; Netherlands; Switzerland; United Kingdom

References

Velders BJJ, Vriesendorp MD, Weissman NJ, Sabik JF 3rd, Reardon MJ, Dagenais F, Moront MG, Rao V, Fukuhara S, Gunzinger R, van Leeuwen WJ, Brown WM, Groenwold RHH, Klautz RJM, Asch FM. Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve. Echocardiography. 2024 Dec;41(12):e70047. doi: 10.1111/echo.70047.

Reference Type: DERIVED

PMID: 39624936 (View on PubMed)

Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.

Reference Type: DERIVED

PMID: 38710669 (View on PubMed)

Velders BJJ, Vriesendorp MD, De Lind Van Wijngaarden RAF, Rao V, Reardon MJ, Shrestha M, Chu MWA, Sabik JF 3rd, Liu F, Klautz RJM. Perioperative care differences of surgical aortic valve replacement between North America and Europe. Heart. 2023 Jun 26;109(14):1106-1112. doi: 10.1136/heartjnl-2023-322350.

Reference Type: DERIVED

PMID: 36963820 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28475690 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PERIGON

Identifier Type: -

Identifier Source: org_study_id