Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT05110066
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee
* Written informed consent from the patient
* Patient age \>17 and \<80 years
* Able to understand and follow instructions and to participate in the entire study period
Exclusion Criteria:
* Life expectancy \<12 months
* Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
* Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
* Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\*
* Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
* Previous balloon pulmonary angioplasty or pulmonary endarterectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT05110066
Study Brief:
Protocol Section:
NCT05110066