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Inspiris Resilia Durability Registry (INDURE)

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: NCT03666741
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief Summary:
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: AVR with or without CABG

Detailed Description:

The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.

The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5.

The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from COMMENCE Trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to VARC-2) is around 0.915. The following table illustrates 95% CIs at different levels of risk:

Sample Size Observed freedom from event 95%CI 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250

20% of registry sites will be monitored with 100% source data verification

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: AVR with or without CABG
    Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™


Primary Outcome Measures :
  1. Time-related valve safety [ Time Frame: Year 1 ]

    Composite endpoint according to VARC-2 depicted as freedom from event:

    • SVD (structural valve deterioration)
    • Valve-related dysfunction
    • Requirement of repeat procedure
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thromboembolic events (e.g. stroke)
    • Valve-related VARC bleeding

  2. Freedom from severe SVD (structural valve deterioration) [ Time Frame: Year 5 ]
    Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients under the age of 60 with an indication for surgical AVR who will receive an Edwards INSPIRIS RESILIA aortic valve prosthesis.
Criteria

Inclusion Criteria:

  1. Age 18 to 60 years inclusive
  2. Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation
  3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery
  4. Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up
  5. Subject provides written informed consent prior to the procedure

Exclusion Criteria:

  1. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
  2. Previous aortic valve replacement
  3. Valve implantation is not possible in accordance with the device IFU
  4. Subject has a life expectancy ≤ 12 months for any reason

Intraoperative Exclusion criteria:

1. Valve implantation is not possible in accordance with the device IFU


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): NCT03666741


Contacts
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Contact: Beate Botta, PhD +49 4471 85033 ext 25 beate.botta@ippmed.de
Contact: Claudia Lüske, PhD +49 4471 85033 ext 24 claudia.lueske@ippmed.de

Locations
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Belgium
KU Leuven Recruiting
Leuven, Belgium
Contact: Bart Meuris, MD         
France
CHRU - Hospital Trousseau Not yet recruiting
Tours, France
Contact: Thierry Bourguignon, MD         
Germany
Heart Center Leipzig Recruiting
Leipzig, Germany
Contact: Michael Borger, MD         
Italy
European Hospital Rome Recruiting
Roma, Italy
Contact: Ruggero de Paulis, MD         
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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Study Director: Peter Bramlage, Professor CEO IPPMed
Principal Investigator: Ruggero dePaulis, Professor European Hospital Rome, Italy
Principal Investigator: Bart Meuris, Professor UZ Leuven, Belgium

Additional Information:

Publications:

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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03666741    
Other Study ID Numbers: HVT-R18-IND
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Surgical valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction