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Sponsored by: |
ELA Medical, Inc. |
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Information provided by: | ELA Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00528320 |
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.
Condition | Intervention |
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Congestive Heart Failure (CHF) |
Device: Ovatio CRT |
Study Type: | Expanded Access |
Official Title: | Clinical Evaluation of Cardiac Resynchronization Therapy With Implantable Cardioverter-Defibrillator Therapy |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gwen Gimmestad | 763-519-9465 | gwen.gimmestad@sorin.com |
Study ID Numbers: | ITAC06 |
Study First Received: | September 10, 2007 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00528320 |
Health Authority: | United States: Food and Drug Administration |
Congestive Heart Failure Heart Failure Cardiac Resynchronization Therapy |
ICD Implantable Cardioverter-Defibrillator Defibrillator |
Heart Failure Heart Diseases |
Cardiovascular Diseases |