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PremiCron Suture for Cardiac Valve Repair (PremiValve)

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ClinicalTrials.gov Identifier: NCT04096859
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
B.Braun Surgical SA
Information provided by (Responsible Party):
Aesculap AG

Brief Summary:
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.

Condition or disease
Aortic Valve Stenosis

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Study Type : Observational
Estimated Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of PremiCron Suture for Cardiac Valve Reconstruction and Replacement. A Multi-centric, Prospective, Single Arm Observational Study in Daily Practice.
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort
PremiCron®
Assessment of PremiCron suture for cardiac valve reconstruction and replacement



Primary Outcome Measures :
  1. a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months [ Time Frame: from intervention up to 6 months postoperative ]

    a composite endpoint of

    • Myocardial infarction until discharge
    • Stroke until discharge
    • Mortality until discharge
    • Endocarditis of the replaced / reconstructed valve until 6 months


Secondary Outcome Measures :
  1. Comparison of mortality at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of mortality until discharge, 30 days and 6 months postop

  2. Comparison of myocardial infarction (MI) at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop

  3. Comparison of stroke at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of stroke until discharge, 30 days and 6 months postop

  4. Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop

  5. Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop

  6. Comparison of atrial fibrillation valve at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of atrial fibrillation until discharge, 30 days and 6 months postop

  7. Comparison of renal failure at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of renal failure until discharge, 30 days and 6 months postop

  8. Comparison of pneumonia at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of pneumonia until discharge, 30 days and 6 months postop

  9. Comparison of mediastinitis at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of mediastinitis until discharge, 30 days and 6 months postop

  10. Comparison of bleeding at different timepoints in postoperative course [ Time Frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop ]
    Incidence of bleeding until discharge, 30 days and 6 months postop

  11. Rate of adverse events [ Time Frame: until 6 months postop ]
    valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related

  12. Length of intensive care unit stay [ Time Frame: until discharge (approximately 10 days postoperative) ]
    Number of days the patient has to stay in intensive care unit after intervention

  13. Length of hospital stay [ Time Frame: until discharge (approximately 10 days postoperative) ]
    Number of days the patient has to stay in hospital

  14. Intraoperative handling of the suture material [ Time Frame: intraoperative ]
    Intraoperative handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale), including pledget assessment

  15. Course of Health Status [ Time Frame: until 6 months postoperative ]
    EQ-5D is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"

  16. Employment status [ Time Frame: preoperative and 6 months postoperative ]
    The employment status of the patient before / after the intervention to evaluate the influence of cardiac valve reconstruction or / and replacement on employment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
Criteria

Inclusion Criteria:

  • Patients undergoing an elective primary open or minimal invasive surgery for a single or multiple cardiac valve reconstruction or / and replacement.
  • Age ≥18 years
  • Written informed consent

Exclusion Criteria:

  • Patients undergoing an elective primary cardiac valve reconstruction or / and replacement in combination with a coronary arterial bypass graft surgery.
  • Emergency surgery
  • Pregnancy
  • Infective endocarditis
  • Previous cardiac surgical intervention
  • Known immunodeficiency or immunosuppression
  • Participation or planned participation in another cardiovascular study before study follow-up is completed.
  • Inability to give informed consent due to mental condition, mental retardation, or language barrier.

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): NCT04096859


Contacts
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Contact: Petra Baumann, Dr. +49-7461-95-1646 petra.baumann@aesculap.de

Locations
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Germany
Robert Bosch KH Stuttgart Not yet recruiting
Stuttgart, Germany, 70376
Contact: Ulrich FW Franke, Prof. Dr. med.    +49-711-8101-3660    ulrich.franke.@rbk.de   
Contact: Adrian Ursulescu, Dr. med.    +49-711-8101-3650    adrian.ursulescu.@rbk.de   
Principal Investigator: Ulrich F.W. Franke, Prof. Dr. med.         
Sub-Investigator: Adrian Ursulescu, Dr. med.         
Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain, 08026
Sponsors and Collaborators
Aesculap AG
B.Braun Surgical SA
Investigators
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Principal Investigator: Ulrich F.W. Franke, Prof. Dr. med. Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery

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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT04096859     History of Changes
Other Study ID Numbers: AAG-O-H-1823
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aesculap AG:
elective surgery
minimally invasive surgery
cardiac valve reconstruction
cardiac valve replacement
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction