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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Femoral Artery Injury; Aortic Valve Insufficiency

Treatments: Other: Data collect

Study type: Observational

Funder types: Other

Identifiers

NCT04802200

HAMDAN 2021

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

204 participants in 1 patient group

Patients operated from minimally invasive cardiac surgery

Description:

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

Treatment:

Other: Data collect