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

NCT04802200 | Completed

• 1 other identifier: HAMDAN 2021
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Artery Injury; Aortic Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Data collect OTHER

Data collect following a vascular closure by MANTA

Patients operated from minimally invasive cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: March 17, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

FR (1)