Actively Recruiting

Age: 15Years +
All Genders
NCT05928234

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

Led by Vastra Gotaland Region · Updated on 2025-03-30

140

Participants Needed

1

Research Sites

76 weeks

Total Duration

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AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals born with pulmonary atresia with intact ventricular septum (PA-IVS) who are 15 years or older at the start of the study.
  • Research subjects who have died after the age of 15 years old are included regarding the mortality variable.
Not Eligible

You will not qualify if you...

  • Individuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pediatric Heart Center, Queen Silvia's Children's hospital

Gothenburg, Sweden, 416 85

Actively Recruiting

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Research Team

S

stina manhem, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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