The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the right ventricle of the heart to the pulmonary arteries. Patients undergoing replacement of their pulmonary valve by transcatheter technique Melody Valve) are at risk of developing such tears in the process of preparing the conduit to accept the new valve. In order to implant such a valve, the connection between the right ventricle and the pulmonary arteries often needs to be enlarged. High pressure balloons may be needed and these balloons can sometimes cause tears in or even rupture of the connecting conduit. Such tears can allow blood to flow into the chest and rarely this can lead to a life-threatening emergency. Experience suggests that such tears can be closed by implanting into the conduit a metallic stent with an outer covering, rebuilding the wall and allowing continuation of the valve implant.
Who can participate
Age range7 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient meets institutional criterion for placement of Melody® TPV
✓. Patient size adequate to receive Melody TPV® implantation via venous access using the Ensemble® Transcatheter Delivery System
✓. RV-PA conduit original size \> 16 mm diameter
✓. Patient age between 10 and 75 years
Exclusion criteria
✕. Patient size too small for transvenous placement of the Melody® TPV
✕. Bloodstream infection, including endocarditis
✕. Pregnancy
✕. Prisoners and adults lacking the capacity to give consent
✕. Conduit size is not suitable (too small or too large) for a Melody® TPV
✕. Risk of coronary compression has been identified
✕
What they're measuring
1
Successful Repair of Conduit Disruption
Timeframe: Implant of Covered Stent and 6 month follow up
. Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study CCPS is prohibited
✕. 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