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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Insufficiency; Femoral Artery Injury
• Intervention / Treatment: Other: Data collect

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject adult voluntarily agreeing to participate in the study operated between December 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital, in whom the MANTA device has been used for femoral artery closure

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients operated from minimally invasive cardiac surgery; 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	Other: Data collect; Data collect following a vascular closure by MANTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2021
• Primary Completion (ACTUAL): October 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (ACTUAL): March 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: HAMDAN 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No