NCT04096859

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 22, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2022

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

September 18, 2019

Last Update Submit

June 19, 2023

Conditions

Aortic Valve Stenosis

Keywords

elective surgeryminimally invasive surgerycardiac valve reconstructioncardiac valve replacement

Outcome Measures

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

    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 Outcomes (16)

  • Comparison of mortality at different timepoints in postoperative course

    until discharge (approximately 10 days postoperative), 30 days and 6 months postop

  • Comparison of myocardial infarction (MI) at different timepoints in postoperative course

    until discharge (approximately 10 days postoperative), 30 days and 6 months postop

  • Comparison of stroke at different timepoints in postoperative course

    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

    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

    until discharge (approximately 10 days postoperative), 30 days and 6 months postop

  • +11 more secondary outcomes

Study Arms (1)

PremiCron®

Assessment of PremiCron suture for cardiac valve reconstruction and replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Robert Bosch KH Stuttgart

Stuttgart, 70376, Germany

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08026, Spain

Location

Related 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/MS9.0000000000000442. eCollection 2023 Apr.

    PMID: 37113912RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Ulrich FW Franke, Prof. Dr. med.

    Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

November 22, 2019

Primary Completion

September 2, 2021

Study Completion

January 13, 2022

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

DE(1)ES(1)