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

• Conditions: Minimally Invasive Cardiac Surgery

• Registration Number: NCT05462769
• Lead Sponsor: Karolinska University Hospital

Brief Summary

A single-center prospective study. Patients undergoing minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA; Teleflex/Essential Medical, Malvern, PA). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-18
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any vascular groin-related complication	During the first 8 weeks after surgery

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden