|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P070008 / PAS001 |
Date Original Protocol Accepted |
05/12/2008
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Date Current Protocol Accepted |
12/23/2010
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Study Name |
CELESTIAL Study
|
Device Name |
STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
Sponsor Registry
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
This study is a 5-year, multi-center prospective cohort study designed to follow at least 2,000 patients implanted with BIOTRONIK's Corox OTW(-S) BP left ventricular lead.
|
Study Population |
The study includes patients who require treatment for advanced heart failure through any CRT-P or CRT-D. Patient must be successfully implanted with a BIOTRONIK CRT system, including a Corox OTW(-S) BP left ventricular lead, from 7-180 days prior to enrollment.
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Sample Size |
This post- approval registry will include a minimum of 2,500 patients from up to 100 sites in the United States with. a minimum of 600 evaluable subjects for the Corox OTW-L BP lead which assumes an equal 1/3 distribution of each lead model (Corox OTW BP LV lead, Corox OTW-S BP LV lead, and Corox OTW-L BP LV lead). The estimated sample size requirement is based on both primary safety endpoints: a non-inferiority comparison (with ä of 5%) of the overall SAE free-rate to 92.5% at 5 years, and a non-powered, superiority comparison for those individual lead-related SAE to 1% at 5 years.
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Key Study Endpoints |
Primary Endpoint 1 evaluates the overall incidence of serious adverse events related to the Corox over-the-wire BiPolar Left Ventricular leads. Primary Endpoint 2 evaluates the incidence of each type of serious adverse events that contributes to Primary Endpoint 1.
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Follow-up Visits and Length of Follow-up |
Patients will be seen for routine follow-up visits per their institutional standard of care (typically every 3-4 months for a cardiac resynchronization therapy-defibrillator and every 6 months for a cardiac resynchronization therapy-pacer), but not to exceed every 6 months.
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Interim or Final Data Summary |
Interim Results |
Thirty patients (5.3%) experienced an adverse event; these were reviewed and adjudicated by the Clinical Events Committee. One primary endpoint adverse event was reported in 565 subjects over a cumulative implant duration of 4227.6 months (352.3 years). The adverse event occurred on day 87, and the current estimated freedom from adverse events is 99.8% for implant times 87 days or longer. There were 36 (8%) subjects with elevated thresholds at implant, and 56 (12%) subjects with elevated thresholds at any follow-up. This number includes all subjects with a threshold greater than 3 Volts or 3.5 Volts, at implant or follow-up respectively, regardless of measured pulse width.
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Actual Number of Patients Enrolled |
2499
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Actual Number of Sites Enrolled |
97
|
Patient Follow-up Rate |
90.1%
|
Final Safety Findings |
Freedom from complication free rate: 94.19%
|
Final Effect Findings |
The LV lead continued to sense and pace appropriately and the percentage of CRT pacing over time remained high
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Study Strengths & Weaknesses |
The study was large, prospective and had long-term follow up. Results demonstrated low adverse event rates. There were minimal weaknesses, aside from study duration.
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Recommendations for Labeling Changes |
Yes, completed
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