Percutaneous Plug-based Arteriotomy Closure Device Use in... | NCT05462769

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

NCT05462769

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

Jul 18, 2022Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Minimally Invasive Cardiac Surgery

Interventions

Percutaneous vascular closure

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jul 14, 2022

First Submission Date that Met QC Criteria

Jul 14, 2022

First Posted Date

Jul 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2022

Last Update Posted Date

Jul 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous vascular closure	Device	Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Any vascular groin-related complication		During the first 8 weeks after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Magnus Dalén	Contact	+46 (0) 8 123 700 00		magnus.dalen@karolinska.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital	Recruiting	Stockholm			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36692172	Derived	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.