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

Minimally Invasive Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462769
• Other study ID #: MANTA continued
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Karolinska University Hospital
• Contact: Magnus Dalén
• Phone: +46 (0) 8 123 700 00
• Email: magnus.dalen[@]karolinska.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Minimally Invasive Cardiac Surgery

Intervention

Device:
• Percutaneous vascular closure
Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any vascular groin-related complication		During the first 8 weeks after surgery