Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery

Aortic Valve Insufficiency Clinical Trial

— MANTA-MICS  

Official title:

Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802200
• Other study ID #: HAMDAN 2021
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Femoral Artery Injury

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