Survival of Double Inlet Left Ventricle (DILV) Patients without Fontan Circulation: Intracardiac Anatomy and Hemodynamics, Functional Status and Quality of life

Survival of Double Inlet Left Ventricle (DILV) Patients without Fontan Circulation: Intracardiac Anatomy and Hemodynamics, Functional Status and Quality of life - Survival of DILV Patients without Fontan circulation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47164

Enrollment

Registered

2018-12-12

Start date

2019-06-11

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

one-chamber heart Univentricular heart

Interventions

Congenital heart disease

Double inlet left ventricle

Survivor

Eligibility

Age

12 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Diagnosis double inlet left ventricle, established by echocardiography or MRI * Not undergone Fontan trajectory in the past * Be of the age of 12 or older * Written informed consent

Exclusion criteria

Exclusion criteria: - previous (partial) cavopulmonary connection - MRI non-compatible pacemaker in situ

Design outcomes

Primary

Measure	Time frame
This is primarily an explorative study aiming to describe the anatomy of unpalliated DILV hearts of patients without Fontan palliation. With 4D MRI, the hearts will be grouped according to the angular relationship of the two lines connecting the atrioventricular and the ventriculo-arterial valves. This angle can be divided into three categories: 1) parallel (i.e. 0°), 2) perpendicular (i.e. 90°) or 3) an in-between variant. Accordingly, flow patterns, ranging from linear to turbulent will be measured and correlated to the anatomical variants.	—

Measure

Time frame

This is primarily an explorative study aiming to describe the anatomy of unpalliated DILV hearts of patients without Fontan palliation. With 4D MRI, the hearts will be grouped according to the angular relationship of the two lines connecting the atrioventricular and the ventriculo-arterial valves. This angle can be divided into three categories: 1) parallel (i.e. 0°), 2) perpendicular (i.e. 90°) or 3) an in-between variant. Accordingly, flow patterns, ranging from linear to turbulent will be measured and correlated to the anatomical variants.

—

Secondary

Measure	Time frame
NYHA functional class, peak oxygen uptake (VO2) during exercise as well as peak VO2 as percentage of predicted (VO2 pred), oxygen saturation at rest, serum biomarkers and quality of life survey scores	—

Countries

Belgium

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)