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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04802200
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Actual Duration (Months): 9.5
• Patients Per Site Per Month: 21.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Artery Injury; Aortic Valve Insufficiency	Other: Data collect

Study Design

• Study Type: Observational
• Actual Enrollment: 204 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
• Actual Study Start Date: Mar 17, 2021
• Actual Primary Completion Date: Oct 30, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourgogne	Dijon		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT04802200
• Other Study ID Numbers: HAMDAN 2021
• First Posted: Mar 17, 2021
• Last Update Posted: Apr 18, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Insufficiency

Study Results

No Results Posted as of Apr 18, 2022