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

Completed

• Conditions: Aortic Valve Insufficiency; Femoral Artery Injury
• Interventions: Other: Data collect

• Registration Number: NCT04802200
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-16
• Study Start: 2021-03-17
• Study First Posted: 2021-03-17
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients operated from minimally invasive cardiac surgery	Data collect	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 and in whom the MANTA device has been used for femoral artery closure

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France