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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130013 / PAS003 |
| Date Original Protocol Accepted |
03/18/2016
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| Date Current Protocol Accepted |
11/30/2016
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| Study Name |
WATCHMAN Comprehensive/Linked-Registry
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| Device Name |
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This Novel Surveillance plan is designed to monitor registry collected data including the following: implant success rate, procedural safety, effective closure of the orifice of the left atrial appendage, and stroke through two years post implant and CMS identification of adverse events of interest and death from two through five years post implant. Patients from a subgroup analysis will have their outcomes compared to pre- specified performance goals for the following: occurrence of composite of stroke (including ischemic or hemorrhagic), systemic embolism, and all cause death at 24 months from the time of implant. The second endpoint is the occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant. The third endpoint is the occurrence of any of the following events within seven days of the implant procedure or by hospital discharge, whichever is later: all cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.
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| Study Population |
Patients with attempted implant of the WATCHMAN device enrolled at sites participating in the LAAO registry.
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| Sample Size |
A minimum of 2000 patients implanted with the WATCHMAN device. At least 1000 of the patients will be match the Indications for Use for the WATCHMAN device. Another 1000 patients will be eligible for the WATCHMAN device, have CHADS score of two or greater or a CHA DS -VASc score of
2 2 2
three or greater, and do not have a concomitant cardiac or
non-cardiac procedure.
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| Key Study Endpoints |
Study Endpoints
Overall surveillance will monitor implant success rate, procedural safety, effective closure of the orifice of the left atrial appendage, and stroke (ischemic or hemorrhagic) through two years post-implant and CMS claims identified occurrence of all stroke (ischemic or hemorrhagic).
For the subgroup analysis the Primary Endpoints follow.
Primary Endpoint 1. The occurrence of the composite stroke (ischemic or hemorrhagic), systemic embolism, and all cause death at 24 months from the time of implant.
Primary Endpoint 2. The occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant.
Primary Endpoint 3. The occurrence of any of the following events within seven days of the procedure or by hospital discharge whichever is later: all cause death, ischemic stroke systemic embolism, or device or procedure realted events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.
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| Follow-up Visits and Length of Follow-up |
Patients will be followed through five years post implant.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
0-2 years: 2000 subjects (1000 subjects each in the LAAO registry primary and LAAO registry secondary cohorts)
3-5 years: 21,963 subjects*
*Patient outcomes during years 3-5 were evaluated via Centers for Medicare and Medicaid Services (CMS) data. Includes all patients implanted with a Watchman device between April 1, 2016 to December 31,
2018 with available CMS claims data.
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| Actual Number of Sites Enrolled |
All sites participating in LAAO registry
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| Patient Follow-up Rate |
45 day: 14/992 (82.1%)
6 months: 700/938 (74.6%)
1 year: 711/891 (79.8%)
2 year: 593/822 (72.1%)
3-5 year: N/A - All available subjects from CMS data
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| Final Safety Findings |
Primary Endpoint 3 (The occurrence of any of the following events within seven days of the procedure or by hospital discharge whichever is later: all cause death, ischemic stroke systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.)
LAAO registry primary cohort at 24 months: 1.4% (14/1000).
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| Final Effect Findings |
Primary Endpoint 1 (The occurrence of the composite stroke (ischemic or hemorrhagic), systemic embolism, and all cause death at 24 months from the time of implant):
LAAO registry primary cohort rate at 24 months: 17.1%
CMS FFS claims rate at 5 years: 44.89%
Primary Endpoint 2 (The occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant):
LAAO registry primary cohort rate at 24 months: 1.24% (12/965).
CMS FFS claim rate at 5 years: 4.77%
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| Study Strengths & Weaknesses |
Strength: Large number of real-world patients enrolled in a relatively short period of time (2 years).
Weakness: Medicare claims data does not characterize medications; thus, medication history as well as current medication regimen, or medication compliance cannot be assessed. Non-Medicare (Patients < 65 years old) and Medicare advantage patients are also excluded from outcomes assessment in years 3 – 5.
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| Recommendations for Labeling Changes |
Update labeling to include long term outcomes
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