Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System
NCT00528320 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2013-11-27
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.
Conditions
- Congestive Heart Failure (CHF)
Interventions
- DEVICE
-
Ovatio CRT
Sponsors & Collaborators
-
ELA Medical, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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