5 results
The objective of this feasibility study is compare the smart AFO + standardized shoes to subjects* own AFO + own shoes. Subjects* experiences with the orthotic devices will be evaluated and points for improvement will be asked. Subjects* performance…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…
To provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302 or TDE-PH-308 or additional UC-15C SR clinical protocols.To assess the long-term safety of UT-15C SR in these subjects through…
The major objective of this clinical investigation is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE* Bi-Directional Catheter and TRUPULSE* Generator) when used for isolation of the atrial PVs in treatment of subjects with…