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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050023 / PAS001 |
| Date Original Protocol Accepted |
08/10/2006
|
| Date Current Protocol Accepted |
08/10/2006
|
| Study Name |
COROX LEAD (COSMO)
|
| Device Name |
TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
In this study patients are enrolled 1-30 days after successful implantation of the Corox OTW Steroid LV lead connected to a BIOTRONIK CRT-D device. Successful implantation is defined as when the pacing threshold of the Corox OTW Steroid LV lead is less than one-half of the maximum programmed output of the BIOTRONIK CRT-D at 0.5 ms without phrenic nerve stimulation.
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| Study Population |
Study Population: Patients implanted with the Corox OTW Steriod LV lead.
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| Sample Size |
250 subjects, at up to 100 sites
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| Key Study Endpoints |
The evaluation of safety is based on the analysis of Corox over-the-wire Steroid lead related adverse events that are classified into two types: observations and complications. Additionally, left ventricular lead pacing parameters (acute and chronic pacing thresholds and impedance values) will be evaluated. The study data will also be used to determine the ability of the Corox over-the-wire steroid lead to deliver chronic cardiac resynchronization pacing.
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| Follow-up Visits and Length of Follow-up |
The patients will be followed for a period of three years. The specific visits that are part of this registry are at enrollment, 3-months, 6-months, 1-year, and routine follow-ups (every subsequent 6 months). It is required that patients are seen at 3, 6, 12, 18, 24, 30, and 36 months post enrollment within ± 1-month at the first (3month) follow-up and at ± 45 days for all subsequent routine follow-ups thereafter.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
221
|
| Actual Number of Sites Enrolled |
34
|
| Patient Follow-up Rate |
59% through three years
|
| Final Safety Findings |
Observations. A total of 23 (10.4%) of the enrolled patients have reported a Corox OTW Steroid Unipolar lead related observation. The rate of Corox OTW Steroid Unipolar lead related observations per patient-year is 0.056. Ten observations were due to high LV lead threshold, 14 were from phrenic nerve stimulation, and one was from intermittent loss of capture.
Complications. A total of 9 (4.1%) of the enrolled patients experienced a Corox OTW Steroid Unipolar lead related complication. The rate of Corox OTW Steroid Unipolar lead related complications per patient-year is 0.019. The eight complications were: LV lead dislodgement (3), phrenic nerve stimulation (1), infection (2), high LV lead threshold (2), and lead integrity compromise (1).
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| Final Effect Findings |
At all scheduled follow-up intervals and interim visits, the CRT system provided appropriate biventricular pacing with capture in 91.9% to 97.8% of subjects. The average overall LV lead impedance was 709 ± 176 ohms. When measured at 0.5 ms pulse width, the average LV lead threshold was 1.3 ± 0.9 ms at enrollment and for all follow-ups was 1.3 ± 1.1 V. In total 1200 subject visits had been reported in 221 subjects.
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| Study Strengths & Weaknesses |
The study results they provide little long term follow-up of the lead. Overall the lead appears to cause few complications although the data collection is weak and adverse events might have occurred but not been reported.
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| Recommendations for Labeling Changes |
Updated to include the long-term post-approval study data and findings.
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