Expired Study
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Mesa, Arizona 85206


Purpose:

The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs


Criteria:

Inclusion Criteria: - Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the "ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" (Zipes et al., JACC Vol. 48, No. 5, Sept. 2006:1064-1108). Exclusion Criteria: - Ventricular tachyarrhythmia that may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes - Incessant tachyarrhythmia - Implanted pacemaker - Primary disorder of bradyarrhythmia or atrial tachyarrhythmia - Of minor age - Pregnant - Participating in another clinical study


NCT ID:

NCT00586378


Primary Contact:

Study Director
Mark J Schwartz, MS
ELA Medical, Inc.


Backup Contact:

N/A


Location Contact:

Mesa, Arizona 85206
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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