SynCardia Freedom Driver System Study

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06174103` - BiVACOR® Total Artificial Heart Early Feasibility Study	N/A
Recruiting	`NCT03659851` - Levosimendan In Patients Undergoing LVAD Implantation
Completed	`NCT00614510` - SynCardia CardioWest TAH-t Postmarket Surveillance Study	N/A

See also

Status

Clinical Trial

Phase

Not yet recruiting

NCT06174103 - BiVACOR® Total Artificial Heart Early Feasibility Study

N/A

Recruiting

NCT03659851 - Levosimendan In Patients Undergoing LVAD Implantation

Completed

NCT00614510 - SynCardia CardioWest TAH-t Postmarket Surveillance Study

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

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.

NCT number	NCT00733447
Study type	Expanded Access
Source	SynCardia Systems. Inc.
Contact
Status	Approved for marketing
Phase	N/A
Start date	March 2010
Completion date	May 2014

SynCardia Freedom Driver System Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms