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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT01824160
Eligibility Criteria:
Inclusion Criteria:
Precatheterization Inclusion Criteria:
1. Patient meets institutional criterion for placement of Melody® TPV
2. Patient size adequate to receive Melody TPV® implantation via venous access using the Ensemble® Transcatheter Delivery System
3. RV-PA conduit original size \> 16 mm diameter
4. Patient age between 10 and 75 years
Catheterization Inclusion Criteria:
a. Angiographic evidence for RV-PA conduit disruption including: dissection, aneurysm, pseudo-aneurysm, tears or rupture
* Recognition and treatment of conduit disruption may occur before, during or after implantation of the Melody® TPV
* Conduit disruption related to prior intervention, identified angiographically before conduit dilation is performed during the Melody® implant procedure, can be eligible for CCPS implantation and study inclusion
Exclusion Criteria:
Precatheterization Exclusion Criteria:
1. Patient size too small for transvenous placement of the Melody® TPV
2. Bloodstream infection, including endocarditis
3. Pregnancy
4. Prisoners and adults lacking the capacity to give consent
Catheterization Exclusion Criteria:
1. Conduit size is not suitable (too small or too large) for a Melody® TPV
2. Risk of coronary compression has been identified
3. Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study CCPS is prohibited
4. Vessel injury occurring in either the right or left branch pulmonary arteries -If injury to branch pulmonary arteries occurs during the catheterization and covered stent usage is indicated, Emergency Use guidelines must be employed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
75 Years
Study:
NCT01824160
Study Brief:
Protocol Section:
NCT01824160