Comparing Outcomes in Heart Patients with Different Circulation Types
A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation
Recruiting
Observational Study
Pulmonary Atresia With Intact Ventricular Septum
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
15 and older
Sex
Any
Study type
Observational
Participants needed
140 (estimated)
Sponsor
Vastra Gotaland Region · Government
Who this trial is looking for
This trial is looking for individuals aged 15 and older who have pulmonary atresia with intact ventricular septum. Participants will answer questions about their quality of life and undergo several heart examinations.
Are You a Good Fit for This Trial?
You may be able to join if
I am 15 years or older
I have pulmonary atresia with intact ventricular septum
You may not be able to join if
I am younger than 15 years old
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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).
Trial Locations
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Eligibility Criteria
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:
Indivi…
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.
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