Aortic Valve StenosisPremiValveNCT04096859
PremiCron Suture for Cardiac Valve Repair
An observational study of Aortic Valve Stenosis, run by Aesculap AG at 2 sites in 2 countries.
Trial summary
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 198 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Nov 2019to 13 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Aortic Valve Stenosis
- Keywords
- elective surgery, minimally invasive surgery, cardiac valve reconstruction, cardiac valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PremiCron® | Assessment of PremiCron suture for cardiac valve reconstruction and replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from intervention up to 6 months postoperative
Secondary outcomes (16)
Comparison of mortality at different timepoints in postoperative course
Incidence of mortality until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of myocardial infarction (MI) at different timepoints in postoperative course
Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of stroke at different timepoints in postoperative course
Incidence of stroke until discharge, 30 days and 6 months postop
Measured: 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
Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop
Measured: 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
Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of atrial fibrillation valve at different timepoints in postoperative course
Incidence of atrial fibrillation until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of renal failure at different timepoints in postoperative course
Incidence of renal failure until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of pneumonia at different timepoints in postoperative course
Incidence of pneumonia until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of mediastinitis at different timepoints in postoperative course
Incidence of mediastinitis until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of bleeding at different timepoints in postoperative course
Incidence of bleeding until discharge, 30 days and 6 months postop
Measured: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Rate of adverse events
valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related
Measured: until 6 months postop
Length of intensive care unit stay
Number of days the patient has to stay in intensive care unit after intervention
Measured: until discharge (approximately 10 days postoperative)
Length of hospital stay
Number of days the patient has to stay in hospital
Measured: until discharge (approximately 10 days postoperative)
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
Measured: intraoperative
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"
Measured: until 6 months postoperative
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
Measured: preoperative and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start22 Nov 2019
- Primary completion2 Sep 2021
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Ulrich FW Franke, Prof. Dr. med., Principal investigator, Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096859
- Sponsor's protocol ID
- AAG-O-H-1823
- Acronym
- PremiValve
- Status last verified
- Jun 2023
- First submitted
- 18 Sep 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37113912
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of PremiCron Suture for Cardiac Valve Reconstruction and Replacement. A Multi-centric, Prospective, Single Arm Observational Study in Daily Practice.
- ClinicalTrials.gov ID
- NCT04096859
- Acronym / sponsor ID
- PremiValve / AAG-O-H-1823
- Conditions
- Aortic Valve Stenosis
- Keywords
- elective surgery, minimally invasive surgery, cardiac valve reconstruction, cardiac valve replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PremiCron® | – | –Assessment of PremiCron suture for cardiac valve reconstruction and replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
16 secondary outcomes
Comparison of mortality at different timepoints in postoperative course
Time frame: 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
Comparison of stroke at different timepoints in postoperative course
Time frame: 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
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
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
Comparison of renal failure at different timepoints in postoperative course
Time frame: 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
Comparison of mediastinitis at different timepoints in postoperative course
Time frame: 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
Rate of adverse events
Time frame: until 6 months postop
Length of intensive care unit stay
Time frame: until discharge (approximately 10 days postoperative)
Length of hospital stay
Time frame: until discharge (approximately 10 days postoperative)
Intraoperative handling of the suture material
Time frame: intraoperative
Course of Health Status
Time frame: until 6 months postoperative
Employment status
Time frame: preoperative and 6 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 37113912Rufa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich FW Franke, Prof. Dr. med. principal investigator
Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Aesculap AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.