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Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum

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ClinicalTrials.gov Identifier: NCT03099967
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Joanna Hlebowicz, Skane University Hospital

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

Condition or disease Intervention/treatment
Congenital Heart Disease Device: Transcatheter closure of an atrial septal defect or patent foramen ovale.

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).

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum
Study Start Date : January 1, 2005
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Intervention Details:
  • Device: Transcatheter closure of an atrial septal defect or patent foramen ovale.
    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).


Primary Outcome Measures :
  1. TnT changes [ Time Frame: Blood samples for TnT were taken one day before intervention and one day after intervention. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fifty one patients who underwent transcatheter ASD and PFO closure (the University Hospital of Lund, Sweden) were studied retrospectively.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • missing TnT values

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Responsible Party: Joanna Hlebowicz, MD, Associated Professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT03099967     History of Changes
Other Study ID Numbers: Interatrial septum 1
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases