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

NCT ID: NCT05462769

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Minimally Invasive Cardiac Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneous vascular closure

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Magnus Dalén

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Magnus Dalén

Role: CONTACT

+46 (0) 8 123 700 00

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Magnus Dalén, MD, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36692172 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MANTA continued

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dacron vs Dardik for Fem-Pop Bypass
NCT00523263 COMPLETED PHASE3
Vein External Support Trial
NCT01415245 COMPLETED NA