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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088554
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date May 1, 2020
Actual Study Start Date  ICMJE May 12, 2014
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death. [ Time Frame: Patients are followed through 5yrs ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance. [ Time Frame: Patients are followed through 5yrs ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PERIGON Pivotal Trial
Official Title  ICMJE 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
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 currently open to capture additional data sets for the size 29mm valve only.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Stenosis
Intervention  ICMJE Device: Model 400 aortic valve bioprosthesis
Study Arms  ICMJE Experimental: Model 400 aortic valve bioprosthesis
Intervention: Device: Model 400 aortic valve bioprosthesis
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
1290
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
650
Estimated Study Completion Date  ICMJE December 31, 2035
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ryan Palmer (763) 514-9732 ryan.j.palmer@medtronic.com
Contact: Jessica Halverson (763) 514-9756 jessica.halverson@medtronic.com
Listed Location Countries  ICMJE Canada,   France,   Germany,   Italy,   Netherlands,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088554
Other Study ID Numbers  ICMJE PERIGON
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiovascular
Study Sponsor  ICMJE Medtronic Cardiovascular
Collaborators  ICMJE Medtronic
Investigators  ICMJE
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
PRS Account Medtronic Cardiovascular
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP