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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT01186692
Eligibility Criteria:
Inclusion Criteria:
* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
* Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)
Exclusion Criteria:
* Implantation in the aortic or mitral position
* Venous anatomy unable to accommodate a 22-fr size introducer sheath
* Obstruction of the central veins
* Clinical or biological signs of infection including active endocarditis
* Unwilling or unable to provide written informed consent or comply with the follow-up requirements
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01186692
Study Brief:
Protocol Section:
NCT01186692