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PERIGON Pivotal Trial (PERIGON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088554
Recruitment Status : Active, not recruiting
First Posted : March 17, 2014
Last Update Posted : March 8, 2023
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Surgery

Study Description
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Brief Summary:
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: Model 400 aortic valve bioprosthesis Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1290 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 12, 2014
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2035

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Model 400 aortic valve bioprosthesis Device: Model 400 aortic valve bioprosthesis


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death. [ Time Frame: A minimum of 15 subjects per valve size will be following through one year ]
    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 :
  1. Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance. [ Time Frame: A minimum of 15 subjects per valve size will be following through one year ]

    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088554


Locations
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Sponsors and Collaborators
Medtronic Cardiac Surgery
Medtronic
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Surgery:
Study Protocol  [PDF] March 13, 2019
Statistical Analysis Plan  [PDF] March 3, 2015
Informed Consent Form  [PDF] March 4, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiac Surgery
ClinicalTrials.gov Identifier: NCT02088554    
Other Study ID Numbers: PERIGON
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction