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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Femoral Artery Injury Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collect

Other

Data collect following a vascular closure by MANTA

Primary outcomes

Occurence of major access site vascular complications

Time frame: 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

Time frame: 10 min

Hemostasis at the puncture site of cutting the MANTA suture without need for manual or mechanical compression and without late re-bleeding

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: MANTA-MICS

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Mar 17, 2021
Registry last updated: Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed