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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050023 / PAS002 |
| Date Original Protocol Accepted |
08/10/2006
|
| Date Current Protocol Accepted |
08/10/2006
|
| Study Name |
TUPOS LV
|
| 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 |
This is a prospective, multi-site post-approval study involving previously implanted Tupos LV/ATx patients who participated in the OPTION CRT/ATx Clinical Investigation. The purpose of this post-approval study is to collect long term survival and long term left ventricular (LV) lead data on patients previously implanted with the Tupos LV/ATx ICD and enrolled into the OPTION CRT/ATx (Cardiac Resynchronization Therapy and Atrial Therapy) clinical investigation.
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| Study Population |
The study population consists of previously implanted Tupos LV/ATx patients who participated in the OPTION CRT/ATx Clinical Investigation. These are patients receiving optimized and stable congestive heart failure (CHF) drug therapy, symptomatic CHF (NYHA class III/IV and LVEF <= 35%), intraventricular conduction delay (QRS 130 ms).
|
| Sample Size |
The post-approval study required following the existing OPTION Tupos LV/ATx patient cohort and did not require enrollment of any new patients with Tupos LV/ATx CRT-D devices. Of the original 129 OPTION CRT/ATx patients successfully implanted with a Tupos LV/ATx, 49 patients still remained actively followed in the OPTION CRT/ATx study when FDA granted approval of the Tupos LV/ATx CRT-D device (P050023) on August 10, 2006. Therefore, since no new enrollment was planned, time to close enrollment is not applicable for this study as enrollment was closed as soon as all 49 active patients were approached and provided consent.
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| Key Study Endpoints |
The post-approval study will report patient mortality, left ventricular (LV) lead capture thresholds and specific left ventricular lead related complications, such as diaphragmatic stimulation and loss of left ventricular capture. In addition, data regarding the Tupos LV/ATx system status, the percentage of patients receiving CRT, and left ventricular lead adverse events will be collected.
|
| Follow-up Visits and Length of Follow-up |
The patients are followed every 3-months for a period of three years. The patient's follow-up schedule is a continuation of the OPTION CRT/ATx follow-up schedule. The follow-up visits coincide with their routine ICD care.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Of the original 129 OPTION CRT/ATx patients successfully implanted with a Tupos LV/ATx, 49 patients remained active for follow-up in the OPTION CRT/ATx study.
|
| Actual Number of Sites Enrolled |
19 sites
|
| Patient Follow-up Rate |
Of the original 129 OPTION CRT/ATx patients successfully implanted with a Tupos LV/ATx, 49 patients remained active for follow-up (every 3-months for a period of three years) in the OPTION CRT/ATx study. Of the 49 patients enrolled in the post approval study, 10 withdrew consent, 4 died, and 35 had the device explanted.
|
| Final Safety Findings |
A total of 119 measurements in 47 patients were performed at routine and interim follow-ups. The average left ventricular lead threshold at 0.5 ms pulse width was 1.7 V with a standard deviation of 1.1 V and a range of 0.5 to 6.0 V. Thirty-three percent of the patients had average thresholds 2.0V or more and 20% of the patients averaged 3.0 V or more. There were many explants due to the end of service life, accounting for 32 of the 34 reported complications. There is quite a bit of variability in the left ventricular lead threshold regardless of the variability associated with the small sample size. However, 80% of the final thresholds were < 3V, and 96% were < 4V.
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| Study Strengths & Weaknesses |
Weakness: Of the 49 patients enrolled in the post-approval study, 10 withdrew consent, 4 died, and 35 had the device explanted.
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| Recommendations for Labeling Changes |
None
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