PremiCron Suture for Cardiac Valve Repair

Aortic Valve Stenosis Clinical Trial

— PremiValve  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096859
• Other study ID #: AAG-O-H-1823
• Status: Completed
• Start date: November 22, 2019
• Est. completion date: January 13, 2022

Study information

• Verified date: June 2023
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 13, 2022
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Locations

Country	Name	City	State
Germany	Robert Bosch KH Stuttgart	Stuttgart
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Countries where clinical trial is conducted

Germany,  Spain, 

References & Publications (1)

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/MS9.000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months	a composite endpoint of; Myocardial infarction until discharge; Stroke until discharge; Mortality until discharge; Endocarditis of the replaced / reconstructed valve until 6 months	from intervention up to 6 months postoperative
Secondary	Comparison of mortality at different timepoints in postoperative course	Incidence of mortality until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of myocardial infarction (MI) at different timepoints in postoperative course	Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of stroke at different timepoints in postoperative course	Incidence of stroke until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course	Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course	Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of atrial fibrillation valve at different timepoints in postoperative course	Incidence of atrial fibrillation until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of renal failure at different timepoints in postoperative course	Incidence of renal failure until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of pneumonia at different timepoints in postoperative course	Incidence of pneumonia until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of mediastinitis at different timepoints in postoperative course	Incidence of mediastinitis until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Comparison of bleeding at different timepoints in postoperative course	Incidence of bleeding until discharge, 30 days and 6 months postop	until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Secondary	Rate of adverse events	valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related	until 6 months postop
Secondary	Length of intensive care unit stay	Number of days the patient has to stay in intensive care unit after intervention	until discharge (approximately 10 days postoperative)
Secondary	Length of hospital stay	Number of days the patient has to stay in hospital	until discharge (approximately 10 days postoperative)
Secondary	Intraoperative handling of the suture material	Intraoperative handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale), including pledget assessment	intraoperative
Secondary	Course of Health Status	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"	until 6 months postoperative
Secondary	Employment status	The employment status of the patient before / after the intervention to evaluate the influence of cardiac valve reconstruction or / and replacement on employment	preoperative and 6 months postoperative