NCT05928234 A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation
| NCT ID | NCT05928234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Pulmonary Atresia With Intact Ventricular Septum |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2024-07-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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: Individuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05928234 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Pulmonary Atresia With Intact Ventricular Septum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05928234 currently recruiting?
Yes, NCT05928234 is actively recruiting participants. Contact the research team at stina.manhem@vgregion.se for enrollment information.
Where is the NCT05928234 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT05928234 clinical trial?
NCT05928234 is sponsored by Vastra Gotaland Region. The trial plans to enroll 140 participants.