Clinical trial NCT04096859: PremiCron Suture for Cardiac Valve Repair
Official title: Assessment of PremiCron Suture for Cardiac Valve Reconstruction and Replacement. A Multi-centric, Prospective, Single Arm Observational Study in Daily Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: elective surgery
minimally invasive surgery
cardiac valve reconstruction
cardiac valve replacement
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2019-09-20
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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


Eligibility 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.

Primary outcomes:
measure: a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months
timeFrame: from intervention up to 6 months postoperative
Secondary outcomes:
measure: Comparison of mortality at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of myocardial infarction (MI) at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of stroke at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of atrial fibrillation valve at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of renal failure at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of pneumonia at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of mediastinitis at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Comparison of bleeding at different timepoints in postoperative course
timeFrame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
measure: Rate of adverse events
timeFrame: until 6 months postop
measure: Length of intensive care unit stay
timeFrame: until discharge (approximately 10 days postoperative)
measure: Length of hospital stay
timeFrame: until discharge (approximately 10 days postoperative)
measure: Intraoperative handling of the suture material
timeFrame: intraoperative
measure: Course of Health Status
timeFrame: until 6 months postoperative
measure: Employment status
timeFrame: preoperative and 6 months postoperative
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch KH Stuttgart
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
Study officials:
affiliation: Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery
name: Ulrich FW Franke, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rufa M, Ursulescu A, Baumann P, Ferrer MT. A prospective, international, bicentric study to evaluate PremiCron suture material for cardiac valve surgery - PREMIVALVE a cohort study. Ann Med Surg (Lond). 2023 Apr 4;85(4):835-841. doi: 10.1097/MS9.0000000000000442. eCollection 2023 Apr.