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|
| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P890003 S354/ PAS001 |
| Study Name |
MR conditional Tachy Therapy Systems
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| Device Name |
CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK PATIENT MONITOR MODEL 24950.
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| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
MR conditional tachyarrhythmia therapy systems enrolled in the Medtronic CareLink® (CL) Network will be used to prospectively assess spontaneous VF episode detection following MRI exposure.
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| Study Population |
All patients who will be implanted with an MR conditional tachyarrhythmia therapy system and followed in the Medtronic CL network with de-identified data accessibility.
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| Sample Size |
A sample size of 50 patients with a true VF episode will produce a 2-sided 95% confidence interval upper bound for the estimate of approximately 11% (i.e. no more than one VF that will have = 5 second detection delay).
The following assumptions were used to define the surveillance scope and duration:
CL participation estimates:
o An estimated 65% of US ICD implants currently enroll in CL and approximately 60% of those patients regularly transmit device data.
o An estimated 69% of US CRT-D implants currently enroll in CL and approximately 55% of those patients regularly transmit device data.
Applying CL use/transmission rate to the current estimated US sales projections:
o An estimated 10,979 MR ICD System Evera MRI patients will be actively monitored in CL within three years of product approval.
o An estimated 14421 MR CRT-D system patients will be actively monitoring within three years of product approval
Annual MRI scan rate of 9%, an estimated 4143 patients will have at least one MRI scan within approximately 4 years post product approval.
Annual true VF/PMVT episode rate of approximately 2%, based on episode adjudication data collected in Medtronic PainFree SST and Shockless studies. Year 1 Year 2 Year 3
Projected US MR ICD Sales per year
6450
10000
11700
Estimated # of Patients
with CareLink Transmissions (0.65|0.6)
2516
3900
4563
Projected US MR CRT-D Sales per year
12000
14000
12000
Estimated # of Patients
with CareLink Transmissions (0.69|0.55)
455
5313
455
Total Estimated (MR ICD + MR CRT-D) with
CareLink Transmissions
7070
9213
9117
MRI after 1 year (0.09 )
635
829
819
MRI after 2 years (0.172)
1214
1583
MRI after 3 years (0.246)
1741
Total Estimated # of Patients with an MRI
4143
Per the above assumptions, a statistical simulation indicates that approximately 40 to 97 patients will have 40 to 194 true VF/PMVT detected episodes, following an MRI, within approximately 5 years of product approval.
|
| Key Study Endpoints |
Primary Endpoints:
To characterize the proportion of episodes with = 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.
No VF/PMVT detection delays of = 5 seconds were observed in the Evera MRI IDE study. A previous Medtronic study estimated a 0.08% detection delay rate in non-MRI patients based on a cohort of 1177 induced VF episodes. Therefore, the probability of observing at least one VF/PMVT episode with = 5 seconds detection delay in the study cohort of 50 patients with VF episodes is 2%.
Other endpoints:
1) Multiple MRI Scans
Data regarding the number of patients presumed to have had 2 or more scans will be provided. The time stamp of a when a device was last programmed to the MRI compatible mode (i.e. SureScan mode) will be tracked from CL transmission to transmission. Any change in the time stamp of an MR mode safe switch of greater than 20 minutes will indicate the occurrence of an MRI. The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode.
2) LV Pacing Capture Threshold
Left ventricular lead Pacing Capture Threshold (PCT) values are automatically stored by the device through the Left Ventricular Capture Management feature and obtained through CareLink transmissions. Pre-MRI and post-MRI4 LV lead PCT measurements obtained through CareLink will be summarized for MR CRT-D patients. Summary statistics will be presented separately for pre-MRI and post-MRI PCT measurements. It is anticipated that PCT measurements from approximately 2,444 patients with a MRI will be presented.
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| Follow-up Visits and Length of Follow-up |
50 patients with a VF episode following MR exposure have been identified or 5-years post-approval, whichever comes first.
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