NCT03697941

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 268 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mitral Valve Disease

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	Surgical cut-down and arterial puncture under direct vision	Surgical cut-down and arterial puncture under direct vision.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2018-10-05
• Last updated: 2019-08-13

Locations

1 site across 1 country: Sweden