Cardiac Troponin T After Transcatheter Closure of the Int... | NCT03099967

Studies
Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum

NCT03099967

Sponsor

Skane University Hospital

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Transcatheter closure of an atrial septal defect or patent foramen ovale.

Countries

Not provided

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2005

Primary Completion Date

Jan 1, 2017Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Mar 29, 2017

First Posted Date

Apr 4, 2017Actual

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

Mar 29, 2017

Last Update Posted Date

Apr 4, 2017Actual

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

To examine retrospectively whether transcatheter closure of the interatrial septum leads to myocardial injury and to determine the mechanism.

Detailed Description

In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).

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

51Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter closure of an atrial septal defect or patent foramen ovale.	Device	In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TnT changes		Blood samples for TnT were taken one day before intervention and one day after intervention.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

transcatheter ASD and PFO closure at the University Hospital of Lund, Sweden

Exclusion Criteria:

missing TnT values

Accepts Healthy Volunteers

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

Fifty one patients who underwent transcatheter ASD and PFO closure (the University Hospital of Lund, Sweden) were studied retrospectively.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided