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Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System

Congestive Heart Failure (CHF) Clinical Trial

Official title:
Clinical Evaluation of Cardiac Resynchronization Therapy With Implantable Cardioverter-defibrillator Therapy

Clinical Trial Summary

This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association [NYHA] Class III or IV).

Quality of life, adverse events and device success will be analyzed and reported.

Clinical Trial Description

ICDs have been shown to increase life expectancy substantially over various drug regimens in patients with life threatening ventricular arrhythmias. Furthermore, large scale studies of cardiac resynchronization therapy in ICD-indicated heart failure patients have demonstrated improvements in functional capacity and quality of life, without unacceptable increases in morbidity or mortality.

This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (NYHA Class III or IV).

Quality of life, adverse events and device success will be analyzed and reported. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00528320
Study type Expanded Access
Source ELA Medical, Inc.
Contact
Status Approved for marketing
Phase N/A
View Details
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