Clinical Research

The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.

Please refer to www.clinicaltrials.gov identifier NCT00614510 for more information.

An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT)

This study provides UT-15C (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed the TDE-PH-301, TDE-PH-302 or TDE-PH-308 studies. The purpose of this study is to assess the long term safety of UT-15C and to assess the effects of continued treatment with UT-15C on exercise capacity after one year of treatment.

This is study is closed to enrollment and is in the follow-up phase.

Please refer to www.clinicaltrials.gov identifier NCT01027949 for more information. 

COMPASS 2: Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study

This study will investigate the effects of the combination of bosentan and sildenafil. Patients with symptomatic PAH treated with a stable dose of sildenafil equal to or greater tha 20 mg t.i.d. for at least 12 weeks will be randomized to placebo or bosentan 125 mg b.i.d. All randomized patients will be treated with study drug until the predefined target number of morbidity/mortality events is reached.

Please refer to www.clinicaltrials.gov identifier NCT00303459 for more information

The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled. Participating patients will be followed for a minimum of five years from the time of enrollment.

This study is not actively recruiting, but in follow-up.

Please refer to www.clinicaltrials.gov identifier NCT00370214 for more information.