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

NCT ID: NCT04802200

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-17

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Artery Injury Aortic Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

Data collect

Intervention Type OTHER

Data collect following a vascular closure by MANTA

Interventions

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Data collect

Data collect following a vascular closure by MANTA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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HAMDAN 2021

Identifier Type: -

Identifier Source: org_study_id

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