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Sudden Cardiac in Systemic Right Ventricle (STARSII)

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ClinicalTrials.gov Identifier: NCT03833843
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
KU Leuven
Erasmus Medical Center
Royal Brompton & Harefield NHS Foundation Trust
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Hospitales Universitarios Virgen del Rocío
Information provided by (Responsible Party):
Magalie Ladouceur, European Georges Pompidou Hospital

Brief Summary:

In complete transposition of the great arteries (TGA) with previous atrial switch repair, and congenitally corrected transposition of the great arteries (ccTGA), the morphological right ventricle and its tricuspid valve continue to support the systemic circulation. This results in late complications including including sudden death.

This retrospective multicentric study aims to evaluate the prevalence of SCD in a contemporary population of patients with a systemic RV and identify specific risk factors for SCD and hemodynamically significant ventricular arrhythmia This registry records demographics, clinical, imaging data, electrophysiological and laboratory of patients with a sRV and a transposition of the great arteries Primary end points are defined by sudden cardiac death, near-miss sudden death, as well as sustained VT requiring defibrillation.


Condition or disease Intervention/treatment
Sudden Cardiac Death Congenital Heart Disease Transposition of Great Vessels Diagnostic Test: imaging

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sudden Cardiac Death in Congenital Heart Diseases With a Systemic Right Ventricle
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TGA Diagnostic Test: imaging
ECG, Echocardiography and cardiac magnetic resonance imaging
Other Name: Blood sample




Primary Outcome Measures :
  1. sudden cardiac death, [ Time Frame: 2000 to 2018 ]
  2. near-miss sudden death [ Time Frame: 2000 to 2018 ]
  3. sustained VT requiring defibrillation [ Time Frame: 2000 to 2018 ]

Secondary Outcome Measures :
  1. all causes of death [ Time Frame: 2000 to 2018 ]
    heart failure, atrial arrhythmia, AV block, stroke



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients (>16 years of age) with sRV and "two-ventricles" circulation, i.e, patients with a transposition of the great arteries palliated by atrial switch procedure and patients with a congenitally corrected transposition of the great arteries, under active follow-up between January 1, 2000 and September 30, 2018
Criteria

Inclusion Criteria:

  • patients >16 years of age
  • sRV and a transposition of the great arteries (TGA or ccTGA) with "two-ventricle circulation"

Exclusion Criteria: congenital heart diaese with univentricular heart physiology


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833843


Contacts
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Contact: magalie Ladouceur, Dr 156093043 ext 33 magalie.ladouceur@aphp.fr

Locations
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France
Hopital Europen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Magalie Ladouceur, Dr    56093043 ext 33    magalie.ladouceur@aphp.fr   
Sponsors and Collaborators
European Georges Pompidou Hospital
KU Leuven
Erasmus Medical Center
Royal Brompton & Harefield NHS Foundation Trust
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Hospitales Universitarios Virgen del Rocío
Investigators
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Principal Investigator: Magalie Ladouceur, Dr Hopital Europeen Georges Pompidou

Publications of Results:
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Responsible Party: Magalie Ladouceur, Dr, European Georges Pompidou Hospital
ClinicalTrials.gov Identifier: NCT03833843     History of Changes
Other Study ID Numbers: STARS
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Death
Heart Defects, Congenital
Death, Sudden, Cardiac
Transposition of Great Vessels
Cardiovascular Diseases
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Arrest
Death, Sudden