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OpenTrials
Completed

NCT Number: NCT04096859

PremiCron Suture for Cardiac Valve Repair

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

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Bosch KH Stuttgart, Stuttgart, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Assessment of PremiCron Suture for Cardiac Valve Reconstruction and Replacement. A Multi-centric, Prospective, Single Arm Observational Study in Daily Practice.

Acronym: PremiValve

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 20, 2019
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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