Haemodynamics and Function of the Atria in Congenital Hea... | NCT02161471

Studies
Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance

NCT02161471

Sponsor

University Children's Hospital, Zurich

Status

Completed

Last Update Posted

Mar 20, 2025Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Coarctation of the Aorta
Tetralogy of Fallot
Transposition of the Great Arteries

Interventions

Not provided

Countries

Switzerland

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 2025

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

Jun 16, 2009Actual

Primary Completion Date

Nov 24, 2009Actual

Completion Date

Nov 24, 2009Actual

First Submitted Date

Jun 10, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 11, 2014Estimated

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 17, 2025

Last Update Posted Date

Mar 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to determine whether patients with repaired congenital heart disease show differences in size or function of their heart atria compared to normal controls and depending on the nature of their heart disease.

Detailed Description

Atrial function is important for good ventricular filling and function. In patients with impaired cardiac function, atrial contraction is even more important. So far, the size and function of the atria have been assessed two-dimensionally by angiography and by echocardiography. However, these do not allow exact characterization of the volumetric changes of the atria during the cardiac cycle. Recently, cardiac magnetic resonance (CMR) has been used to assess size and function of the left atrium in adults. Little data are available about function and volume of the atria in children and the role of the atria in congenital heart disease (CHD).

The study will recruit patients with CHD (n=40) and normal controls (n=10). The patient group will be composed by patients suffering from the following conditions: coarctation of the aorta (n=10), tetralogy of Fallot (n=10), transposition of the great arteries after atrial switch (Senning procedure) (n=10), transposition of the great arteries after arterial switch operation (n=10).

The study consists of measurements of sizes and function of the right and the left atrium, respectively, by examining three-dimensional volume changes across the heart cycle, and of phase contrast measurements of blood flow across the valves of the heart.

Conditions Module

Conditions

Coarctation of the Aorta
Tetralogy of Fallot
Transposition of the Great Arteries

Keywords

Atria, Heart
Function, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Tetralogy, Fallot
Transposition of Great Arteries
Coarctation of the Aorta

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tetralogy of Fallot		Patients after repair of tetralogy of Fallot
Normal		Normal controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Right and left atrial volume	Measurement of maximal volume (at end of systole), volume before atrial contraction (in late diastole), and minimal volume (at end of diastole) of both atria.	Day of CMR (baseline only, no intervention)

Secondary Outcomes

Measure	Description	Time Frame
Blood flow across the atrio-ventricular valves	Phase contrast measurement of blood flow across the atrio-ventricular and the ventriculo-arterial valves, respectively, to serve as an internal validation of total atrial emptying volumes, as well as to contribute maximum early and late diastolic velocities.	Day of CMR (baseline only, no intervention)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to perform repetitive breath holds of 10-15 seconds each
Written informed consent of the patients or their legal guardians

Exclusion Criteria:

Patients requiring general anaesthesia
Residual cardiac findings which might potentially influence the size and function of the atria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants for the study will be recruited among patients, children and adults, with CHD (groups 1-4) undergoing cardiac magnetic resonance examination for clinical reasons.

Patients after repair of coarctation of the aorta
Patients after repair of tetralogy of Fallot
Patients with transposition of the great arteries after atrial switch (Senning procedure)
Patients with transposition of the great arteries after arterial switch operation
Children without cardiovascular anomalies undergoing CMR for other clinical reasons not influencing cardiac function (control group)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emanuela R Valsangiacomo Buechel, Prof.	University Children's Hospital Zürich, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital Zürich, Switzerland		Zurich	Canton of Zurich	8032	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001017	Aortic Coarctation
D013771	Tetralogy of Fallot
D014188	Transposition of Great Vessels
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided