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

NCT05462769 | Unknown

• 1 other identifier: MANTA continued
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimally Invasive Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Any vascular groin-related complication

  During the first 8 weeks after surgery

Interventions

Percutaneous vascular closure DEVICE

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 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.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Related Publications (1)

• Ma K, Kastengren M, Svenarud P, Green R, Dalen M. Routine use of percutaneous femoral cannulation in minimally invasive cardiac surgery. Eur J Cardiothorac Surg. 2023 Mar 1;63(3):ezad020. doi: 10.1093/ejcts/ezad020.

  PMID: 36692172 DERIVED

Central Study Contacts

Magnus Dalén

CONTACT

+46 (0) 8 123 700 00; magnus.dalen@karolinska.se

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: July 14, 2022
• First Posted: July 18, 2022
• Study Start: August 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)