|
General |
Study Status |
Other |
Application Number / Requirement Number |
P060027 / PAS001 |
Date Original Protocol Accepted |
10/31/2008
|
Date Current Protocol Accepted |
10/31/2008
|
Study Name |
Long Term
|
Device Name |
OVATIO CRT SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective & Retrospective Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The post-approval study is a 5-year, multi-center, single arm, prospective and retrospective cohort study. All subjects in the study receive the device.
|
Study Population |
Study population same as approved product. Indication for use: Ovatio cardiac resynchronization therapy is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized New York Heart Association Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer. Situs over-the-wire is designed to pace the left ventricle through a coronary vein. It is intended to be used in conjunction with ELA Medical cardiac resynchronization therapy pulse generators.
|
Sample Size |
2260 subjects, 20 sites
|
Key Study Endpoints |
Endpoints include complication free rate at 5 years, individual adverse event rates through 5 years, and system complication free rate at 6 months.
|
Follow-up Visits and Length of Follow-up |
Scheduled follow-up occurs at discharge, one month, 6 months, and every 6 months thereafter, for five years post-implant. Unscheduled visits may occur for adverse events. At each scheduled visit, patients are queried regarding adverse events and device interrogation is performed.
|