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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04802200
Other study ID # HAMDAN 2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 17, 2021
Est. completion date December 31, 2021

Study information

Verified date April 2022
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter Aortic Valve Implantation. Data concerning safety and efficacy of MANTA Vascular Closure Device in Minimally Invasive Cardiac Surgery are scarce. This study aim to assess this novel collagen-based technology in minimal invasive aortic valve replacement surgery.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date December 31, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject voluntarily agreeing to participate in the study - Subject >= 18 years of age - Patients operated between december 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital - Patients in whom the MANTA device has been used for femoral artery closure Exclusion Criteria: Not applicable

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collect
Data collect following a vascular closure by MANTA

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurence of major access site vascular complications according to the Valve Academic Research Consortium (VARC)-2 and Bleeding Academic Research Consortium (BARC)-2 definition criteria in postoperative period 30 days
Primary Hemostasis success Hemostasis at the puncture site of cutting the MANTA suture without need for manual or mechanical compression and without late re-bleeding 10 min
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