PremiCron Suture for Cardiac Valve Repair (PremiValve)

June 19, 2023 updated by: Aesculap AG

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70376
        • Robert Bosch KH Stuttgart
  • Spain
      • Barcelona, Spain, 08026
        • Hospital de La Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from intervention up to 6 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: until discharge (approximately 10 days postoperative)
Number of days the patient has to stay in hospital
until discharge (approximately 10 days postoperative)
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
until discharge (approximately 10 days postoperative)
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until discharge (approximately 10 days postoperative), 30 days and 6 months postop
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
until 6 months postop
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
intraoperative
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"
until 6 months postoperative
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
preoperative and 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Investigators

  • Principal Investigator: Ulrich FW Franke, Prof. Dr. med., Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Actual)

September 2, 2021

Study Completion (Actual)

January 13, 2022

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1823

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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