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:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT01250327
Eligibility Criteria:
Inclusion Criteria:
for the study:
* Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation
for the Melody arm:
* A 5 to 70 years old patient
* Weight \>= 30kg
* RVOT \<= to 22mm
* Patient with a dysfunction circumferential prosthetic conduct of diameter \>= to 16mm.
Exclusion Criteria:
* Vein anatomy incompatibility with a 22Fr delivery health
* Left heart implantation
* RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
* Coronary anomaly with a coronary artery naer the RVOT
* Sever obstruction of the RVOT incompatible with balloon expansion
* Central vein obstruction
* Ongoing infection
* Active endocarditis
* Allergy for heparin or aspirin
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
70 Years
Study:
NCT01250327
Study Brief:
Protocol Section:
NCT01250327