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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010031 S563/ PAS001 |
| Date Original Protocol Accepted |
03/24/2017
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| Date Current Protocol Accepted |
|
| Study Name |
MPP PAS
|
| Device Name |
Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchronization.
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Descriptive
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A global, prospective, observational, multi-center study following patients implanted with a CRT Quad system and enrolled in the Product
Surveillance Registry per the expected standard of care practices of their care provider. The study requires regular reporting of CRT response
assessments. Data capture will be reflective of real-world clinical practice in terms of how physicians assess a patients’ response to CRT
and what actions they may take to improve response. The study provides an estimate of the nonresponder rate and estimates the
proportion of patients who are converted from a non-responder to a responder with the use of the MPP feature.
|
| Study Population |
Patients who are considered non-responders to traditional CRT. The patient population is its own control group.
|
| Sample Size |
A sample size of 1250 patients assuming 20% of the patients are identified as a surviving CRT non-responder, of which 50% have MPP
enabled produces a 95% confidence interval width of 16.5%, if the MPP responder rate is 30%. The primary objective will be analyzed when a
sample size of 118 CRT non-responders with MPP enabled is achieved or at 3 years after the approval of the MPP feature whichever comes first.
|
| Key Study Endpoints |
To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT therapy.
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| Follow-up Visits and Length of Follow-up |
duration of the study
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| Interim or Final Data Summary |
| Interim Results |
Number of IRB Approvals 80 IRB approvals
Number of study sites enrolled 80 Clinical Sites
Number of subjects enrolled 1515 Subjects Enrolled
Data Quality/Inconsistencies 45 study exits (not including deaths), 11 deviations
Key Safety Findings 90 deaths
41 of these events were due to cardiac death. There were 149 (of 184 adjudicated) reported Heart Failure Events and 115 heart Failure hospitalizations.
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| Actual Number of Patients Enrolled |
1514 patients
|
| Actual Number of Sites Enrolled |
71 sites
|
| Patient Follow-up Rate |
The overall follow-up rate was 92.1%
|
| Final Safety Findings |
There were no HF hospitalizations after MPP enabled for the four subjects in the primary objective cohort. There was one death of subject in the primary objective cohort after MPP enabled, this was assessed as not system-related.
|
| Final Effect Findings |
Primary Objective: To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT therapy and had MPP programmed “on
• 581 (38.4%) of the 1514 enrolled patients completed a CRT response assessment between 3-9 months post CRT implant AND prior to MPP enabled (if enabled).
• A total of 108 (18.6%) patients were identified as non-responders to CRT therapy
• Seven (7) patients had the MPP functionality turned on subsequent to the visit. Of the seven (7) patients reported to have MPP programmed on at least three months post implant, four (4) maintained MPP enabled for at least three additional months as evidenced in their device data and therefore contribute to the primary objective analysis cohort.
Secondary Objectives: Summarize patient baseline characteristics including but not limited to NYHA class, QRS duration, bundle branch morphology, LV lead implant location, etc.
• Of the enrolled 1514 patients, 1026 patients (67.8%) received a CRT-D device while 488 patients (32.2%) received a CRT-P. The majority of patients enrolled were NYHA class II (27.4%) or III (37.0%), and NYHA class was missing for 30.1%. For 1292 patients QRS was assessed and average QRS duration was 154.3 ms with a standard deviation of 30.8. Around half of the patients had left bundle branch block (52.3%). The majority of LV leads were implanted in the left ventricle posterior lateral vein (30.3%) or the left ventricle lateral (marginal) vein (27.7%).
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| Study Strengths & Weaknesses |
There were far fewer patients than expected to fall under the primary objective analysis cohort. As there were only four (4) patients, the utilization rate was too low to analyze. The low utilization rate was confirmed by real-world MPP usage rates from the Medtronic CareLink network.
This study provided general descriptive information of CRT-D and CRT-P utilization among different NYHA class patients as well as data on the average QRS duration and lead placement during implantation. This is unrelated to the investigational device (MPP)
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| Recommendations for Labeling Changes |
Yes
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