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PERIGON Pivotal Trial (PERIGON)

Primary Purpose

Aortic Stenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Model 400 aortic valve bioprosthesis
Sponsored by
Medtronic Cardiac Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California (USC) University Hospital
  • University of Colorado Hospital
  • Hartford Hospital
  • University of Florida Shands
  • Piedmont Hospital
  • University of Maryland Medical Center
  • Massachusetts General Hospital
  • University of Michigan Cardiovascular Center
  • Minneapolis Heart Institute Foundation
  • Maimonides Medical Center
  • The Mount Sinai Medical Center
  • New York-Presbyterian Hospital/Columbia University Medical Center
  • Cleveland Clinic
  • Riverside Methodist Hospital (OhioHealth)
  • ProMedica Toledo Hospital
  • Oklahoma Heart Hospital
  • Cardiothoracic and Vascular Surgeons (CTVS)
  • Houston Methodist Hospital
  • University of Washington Medical Center
  • Aurora Saint Luke's Medical Center
  • London Health Sciences Centre - University Campus
  • University of Ottawa Heart Institute
  • Montreal Heart Institute
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
  • Toronto General Hospital
  • Hôpital Cardiologique du Haut-Lévêque
  • Hôpital Bichat - Claude Bernard
  • Uniklinik Köln
  • Deutsches Herzzentrum München
  • Universitäts Klinikum Frankfurt - Goethe-Universität
  • Medizinische Hochschule Hannover
  • Herzzentrum Leipzig GmbH
  • Ospedale San Raffaele - Milano
  • Leids Universitair Medisch Centrum (LUMC)
  • Erasmus MC
  • Inselspital - Universitätsspital Bern
  • UniversitätsSpital Zürich
  • Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Model 400 aortic valve bioprosthesis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 4, 2014
Last Updated
April 27, 2023
Sponsor
Medtronic Cardiac Surgery
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02088554
Brief Title
PERIGON Pivotal Trial
Acronym
PERIGON
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2014 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
December 31, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Surgery
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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, with each site following a common protocol. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Model 400 aortic valve bioprosthesis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Model 400 aortic valve bioprosthesis
Primary Outcome Measure Information:
Title
Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death.
Description
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.
Time Frame
A minimum of 15 subjects per valve size will be following through one year
Secondary Outcome Measure Information:
Title
Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance.
Description
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.
Time Frame
A minimum of 15 subjects per valve size will be following through one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 Patient has renal failure, defined as dialysis therapy or GFR<30 mL/min/1.73 m2 Patient has hyperparathyroidism Patient is participating in another investigational device or drug trial or observational competitive study Patient is pregnant, lactating or planning to become pregnant during the trial period Patient has a documented history of substance (drug or alcohol) abuse Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography Patient has systolic EF<20% as assessed by echocardiography Patient has Grade IV Diastolic Dysfunction Patient has documented bleeding diatheses Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment Patient requires emergency surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Sabik, MD
Organizational Affiliation
University Hospital Cleveland Medical Center (Not a recruiting site)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Robert Johannes Menno Klautz, MD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California (USC) University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-5313
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2545
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
University of Florida Shands
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Cardiovascular Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5853
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407-1139
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York-Presbyterian Hospital/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
Riverside Methodist Hospital (OhioHealth)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Cardiothoracic and Vascular Surgeons (CTVS)
City
Austin
State/Province
Texas
ZIP/Postal Code
78756-4080
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-0001
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215-4330
Country
United States
Facility Name
London Health Sciences Centre - University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Hôpital Cardiologique du Haut-Lévêque
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Uniklinik Köln
City
Cologne
State/Province
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
Munich
State/Province
München
ZIP/Postal Code
DE 80636
Country
Germany
Facility Name
Universitäts Klinikum Frankfurt - Goethe-Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Ospedale San Raffaele - Milano
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Inselspital - Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28475690
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.
Results Reference
derived

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PERIGON Pivotal Trial

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