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

Completed

• Conditions: Mitral Valve Disease
• Interventions: Procedure: Surgical cut-down and arterial puncture under direct vision; Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

• Registration Number: NCT03697941
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Primary Completion: 2019-03
• Study Completion: 2019-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical cut-down and arterial puncture under direct vision	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	-

Primary Outcome Measures

Name	Time	Method
Major vascular groin-related complication according to the VARC-2 definition criteria	During the first 8 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Access-site related groin seroma	During the first 8 weeks after surgery
Access-site related groin infection	During the first 8 weeks after surgery
Minor vascular groin-related complication according to the VARC-2 definition criteria	During the first 8 weeks after surgery

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden