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Clinical Trials in Sweden / NCT05928234
Active, not recruiting Observational

A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation

NCT05928234 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2024-07-15
Last updated
2026-08-28

Condition(s) studied

Pulmonary Atresia With Intact Ventricular Septum

Study summary

The goal of this observational study is to compare patients with pulmonary atresia with intact ventricular septum (PA-IVS) with univentricular circulation to patients with the same heart defect but that has a biventricular circulation in regards to mortality, quality of life, comorbidity, cardiac function, and work capacity. The main questions the study aims to answer are:

• Do mortality, quality of life, comorbidity, cardiac function, and work capacity differ between patients with PA-IVS who have univentricular and biventricular circulation?

Participants will be asked to answer a Quality of Life questionnaire. The investigators will also inquire with a sample size of the research subjects (based on place of residence) about their participation in a series of examinations (ergo-spirometry to assess work capacity, transthoracic echocardiogram, magnetic resonance of the heart and blood sampling to assess cardiac function and cardiac health).

Eligibility

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Individuals born with pulmonary atresia with intact ventricular septum (PA-IVS) who are 15 years or older at the start of the study. * Regarding the mortality variable, research subjects who have died after the age of 15 years old will be included. Exclusion Criteria: Individuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Pediatric Heart Center, Queen Silvia's Children's hospital Gothenburg Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05928234 on ClinicalTrials.gov ↗ ← All trials in Sweden