NCT03833843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

February 6, 2019

Last Update Submit

May 17, 2021

Conditions

Sudden Cardiac DeathCongenital Heart DiseaseTransposition of Great Vessels

Outcome Measures

Primary Outcomes (3)

  • sudden cardiac death,

    2000 to 2018

  • near-miss sudden death

    2000 to 2018

  • sustained VT requiring defibrillation

    2000 to 2018

Secondary Outcomes (1)

  • all causes of death

    2000 to 2018

Study Arms (1)

TGA

Diagnostic Test: imaging

Interventions

imagingDIAGNOSTIC_TEST

ECG, Echocardiography and cardiac magnetic resonance imaging

Also known as: Blood sample
TGA

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Europen Georges Pompidou

Paris, 75015, France

Location

Related Publications (3)

  • Kammeraad JA, van Deurzen CH, Sreeram N, Bink-Boelkens MT, Ottenkamp J, Helbing WA, Lam J, Sobotka-Plojhar MA, Daniels O, Balaji S. Predictors of sudden cardiac death after Mustard or Senning repair for transposition of the great arteries. J Am Coll Cardiol. 2004 Sep 1;44(5):1095-102. doi: 10.1016/j.jacc.2004.05.073.

    PMID: 15337224RESULT

  • Schwerzmann M, Salehian O, Harris L, Siu SC, Williams WG, Webb GD, Colman JM, Redington A, Silversides CK. Ventricular arrhythmias and sudden death in adults after a Mustard operation for transposition of the great arteries. Eur Heart J. 2009 Aug;30(15):1873-9. doi: 10.1093/eurheartj/ehp179. Epub 2009 May 22.

    PMID: 19465439RESULT

  • Khairy P, Harris L, Landzberg MJ, Fernandes SM, Barlow A, Mercier LA, Viswanathan S, Chetaille P, Gordon E, Dore A, Cecchin F. Sudden death and defibrillators in transposition of the great arteries with intra-atrial baffles: a multicenter study. Circ Arrhythm Electrophysiol. 2008 Oct;1(4):250-7. doi: 10.1161/CIRCEP.108.776120. Epub 2008 Sep 12.

    PMID: 19808416RESULT

MeSH Terms

Conditions

Death, Sudden, CardiacHeart Defects, CongenitalTransposition of Great Vessels

Interventions

Diagnostic ImagingBlood Specimen Collection

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Magalie Ladouceur, Dr

    Hopital Europeen Georges Pompidou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 7, 2019

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 18, 2021

Record last verified: 2021-05

Locations

FR(1)