Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery

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

268 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-06-30

Brief Summary

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A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review and from the Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) electronic data collection platform.

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Detailed Description

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Conditions

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Mitral Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical cut-down and arterial puncture under direct vision

Intervention Type PROCEDURE

Surgical cut-down and arterial puncture under direct vision.

Percutaneous arteriotomy closed with closure device

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Intervention Type PROCEDURE

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).

Interventions

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Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).

Intervention Type PROCEDURE

Surgical cut-down and arterial puncture under direct vision

Surgical cut-down and arterial puncture under direct vision.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.