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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT05090228
Eligibility Criteria:
Inclusion Criteria:
* Individual should meet the European Society of Cardiology criteria for pulmonary valve intervention according to congenital heart disease guidelines.
* Individual has an indication for PVR or PPVI according to the local GUCH heart team
* Individual is ≥18 years of age.
* Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.
* Patients are acceptable candidates for PVR or PPVI treatment in accordance with manufacturer's instructions for use.
Exclusion Criteria:
* Individual is younger than 18 years of age.
* Individual has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD (Modification of Diet in Renal Disease) calculation.
* Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia).
* Individual is pregnant, nursing or planning to be pregnant.
* Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
* Individual is currently enrolled in an investigational drug or device trial.
* Individual with any contraindications for MRI:
1. The presence of implanted non-MRI-compatible cardiac pacemaker or implanted cardioverter defibrillator.
2. Implanted electronic devices like cochlear implants and nerve stimulators.
3. Patients who are unable to fit into the bore of the magnet.
4. Claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05090228
Study Brief:
Protocol Section:
NCT05090228