SynCardia CardioWest TAH-t Postmarket Surveillance Study

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

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.

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06174103` - BiVACOR® Total Artificial Heart Early Feasibility Study	N/A
Approved for marketing	`NCT00733447` - SynCardia Freedom Driver System Study	N/A
Recruiting	`NCT03659851` - Levosimendan In Patients Undergoing LVAD Implantation

NCT number	NCT00614510
Study type	Observational
Source	SynCardia Systems. Inc.
Contact
Status	Completed
Phase	N/A
Start date	August 2006
Completion date	March 2015

SynCardia CardioWest TAH-t Postmarket Surveillance Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms