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NCT03697941 Clinical Trial

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

Mitral Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03697941
Other study ID # MIMVS-MANTA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date June 2019

Study information
Verified date August 2019
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 268
Est. completion date June 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).
• Surgical cut-down and arterial puncture under direct vision
Surgical cut-down and arterial puncture under direct vision.

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