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

NCT03697941 | Completed

• 1 other identifier: MIMVS-MANTA
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• Major vascular groin-related complication according to the VARC-2 definition criteria

  During the first 8 weeks after surgery

Secondary Outcomes (3)

• Minor vascular groin-related complication according to the VARC-2 definition criteria

  During the first 8 weeks after surgery

• Access-site related groin seroma

  During the first 8 weeks after surgery

• Access-site related groin infection

  During the first 8 weeks after surgery

Study Arms (2)

Surgical cut-down and arterial puncture under direct vision

Procedure: Surgical cut-down and arterial puncture under direct vision

Percutaneous arteriotomy closed with closure device

Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Interventions

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device PROCEDURE

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).

Percutaneous arteriotomy closed with closure device

Surgical cut-down and arterial puncture under direct vision PROCEDURE

Surgical cut-down and arterial puncture under direct vision.

Surgical cut-down and arterial puncture under direct vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patientes 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.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Kastengren M, Svenarud P, Kallner G, Settergren M, Franco-Cereceda A, Dalen M. Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery. Ann Thorac Surg. 2020 Jul;110(1):85-91. doi: 10.1016/j.athoracsur.2019.10.038. Epub 2019 Nov 30.

  PMID: 31794742 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: February 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)