PERIGON Pivotal Trial

NCT02088554 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: PERIGON
• Study Type: interventional
• Target: 1,312
• Locations: 8 countries
• Sites: 38

Brief Summary

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

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

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

• Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant

  A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.

  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 the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year

  A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.

  Measured at 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 Mean Pressure Gradient (mmHg) Through 1 Year Post-implant

  A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.

  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 Performance Index (L/Min) Through 1 Year Post-implant

  A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.

  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 Cardiac Output (L/Min) Through 1 Year Post-implant

  Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory.

  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 Cardiac Index (L/Min/m^2) Through 1 Year Post-implant

  A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.

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

Secondary Outcomes (9)

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

  Annually, at years 2, 3, 4, and 5 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 5 Years Post-implant

  Annually, at years 2, 3, 4, and 5 post-implant

• Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure

  Annually, at years 2, 3, 4, and 5 post-implant

• Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant

  Annually, at years 2, 3, 4, and 5 post-implant

• 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

  Annually, at years 2, 3, 4, and 5 post-implant

Other Outcomes (20)

• 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)

  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 (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

  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 (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

  3-6 months, 1 year post-implant

Study Arms (1)

Model 400 aortic valve bioprosthesis

EXPERIMENTAL

Device: Model 400 aortic valve bioprosthesis

Interventions

Model 400 aortic valve bioprosthesis DEVICE

Model 400 aortic valve bioprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead
• Medtronic: collaborator

Study Sites (38)

University of Southern California (USC) University Hospital

Los Angeles, California, 90033-5313, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045-2545, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Florida Shands

Gainesville, Florida, 32610, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109-5853, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407-1139, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195-0001, United States

Location

Riverside Methodist Hospital (OhioHealth)

Columbus, Ohio, 43214, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73135, United States

Location

Cardiothoracic and Vascular Surgeons (CTVS)

Austin, Texas, 78756-4080, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-0001, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215-4330, United States

Location

London Health Sciences Centre - University Campus

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, G1V 4G5, Canada

Location

Toronto General Hospital

Toronto, M5G 2C4, Canada

Location

Hôpital Cardiologique du Haut-Lévêque

Bordeaux, 33604, France

Location

Hôpital Bichat - Claude Bernard

Paris, 75018, France

Location

Uniklinik Köln

Cologne, Köln, 50924, Germany

Location

Deutsches Herzzentrum München

Munich, München, DE 80636, Germany

Location

Universitäts Klinikum Frankfurt - Goethe-Universität

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Ospedale San Raffaele - Milano

Milan, 20132, Italy

Location

Leids Universitair Medisch Centrum (LUMC)

Leiden, 2333 ZA, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

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

London, SE1 7EH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 39624936 DERIVED

• 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.

  PMID: 38710669 DERIVED

• 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.

  PMID: 36963820 DERIVED

• 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.

  PMID: 28475690 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Jessica Halverson, Director of Clinical Research
• Organization: Medtronic

rsperigonpivotaltrial@medtronic.com

(800) 633-8766

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 17, 2014
• Study Start: May 12, 2014
• Primary Completion: April 17, 2023
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 29, 2026
• Results First Posted: June 4, 2024

Record last verified: 2026-04

Locations

GB (1); CH (2); FR (2); NL (2); US (20); IT (1); DE (5); CA (5)