Overview of Clinical Research Trials

The PrepMD student will learn the reporting mechanisms for clinical research utilizing medical devices. This will include the various phases of clinical research, and the Medical Device Safety Act Passed in 1990.

The Investigational Device Exemption (IDE) application process will be discussed along with the responsibilities for reporting adverse affects and serious complications related to device use and testing.

In depth discussion of landmark clinical trials will be reviewed providing insight to the growth of the CRM industry through expanded patient indications.

Historical CRM Clinical Trials:

REVERSE, 2008 – CRT vs no CRT

RethinQ, 2007 – Combined CRT + ICD vs no CRT

CARE-HF, 2005 – CRT vs no CRT

SCD-HeFT (ICD vs placebo), 2005 – ICD vs no ICD

SCD-HeFT (ICD vs amiodarone), 2005 – ICD vs no ICD

MIRACLE-ICD-II, 2004 – Combined CRT + ICD vs ICD alone

COMPANION (CRT+ICD vs CRT), 2004 – Combined CRT + ICD vs CRT

DEFINITE, 2004 – ICD vs no ICD

DINAMIT, 2004 – ICD vs no ICD

COMPANION (CRT+ICD vs MT), 2004 – Combined CRT + ICD vs no CRT no ICD

COMPANION (CRT vs MT), 2004 – CRT vs no CRT

MIRACLE-ICD-I, 2003 – Combined CRT + ICD vs ICD alone

CONTAK-CD , 2003 – Combined CRT + ICD vs ICD alone

AMIOVIRT, 2003 – Combined CRT + ICD vs no CRT no ICD

RD-CHF, 2003 – CRT vs no CRT

MUSTIC AF, 2002 – CRT vs no CRT

MADIT-II, 2002 – ICD vs no ICD

PATH-CHF, 2002 – CRT vs no CRT

Garrigue, 2002 – CRT vs no CRT

MIRACLE, 2002 – CRT vs no CRT

CAT, 2002 – ICD vs no ICD

MUSTIC-SR, 2001 – CRT vs no CRT

MUSIT, 1999 – ICD vs no ICD

CABG-patch, 1997 – ICD vs no ICD

MADIT, 1996 – ICD vs no ICD