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.
Cardiomyopathy Treatment Program
Page Scovel, RN
The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.
Please refer to www.clinicaltrials.gov identifier NCT00733447 for more information.
Champion: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
HF Pressure Measurement System
The primary hypothesis is that the TREATMENT group will have a significantly lower rate of HF-related hospitalizations than the CONTROL group. ( Time Frame: 6 months). This trial is closed to enrollment and is follow-up phase.
This trial is closed to enrollment and continues in follow up phase.
Cynthia Larew RN 319-356-1028 pager # 2123
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure. The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay heart failure related hospitalizations in persons with advanced heart failure when added to their maximal and optimized therapy.
Please refer to www.clinicaltrials.gov identifier NCT01643330
for more information.
A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure (CUPID-2b)
Cynthia Larew, RN BSN
The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
This study is closed to enrollment and is in follow-up phase.
Please refer to www.clinicaltrials.gov identifier NCT01065454 for more information.
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