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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130013 S057/ PAS001 |
| Date Original Protocol Accepted |
10/31/2023
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| Date Current Protocol Accepted |
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| Study Name |
SURPASS Pro
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| Device Name |
WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
SURPASS Pro is an observational, prospective, non-randomized, multicenter registry surveillance analysis plan for all patients entered into the LAAO Registry who had a WATCHMAN FLX Pro Device implant attempt. This surveillance is designed to monitor data including: .
ischemic stroke and systemic embolism at hospital discharge, 45 days, 6 months, 12 months, and 24 months post-procedure. The surveillance should also monitor the rate of 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 within seven days of the procedure or by hospital discharge, whichever is later.
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| Study Population |
SURPASS Pro data will include all patients enrolled in the LAAO Registry who had a WATCHMAN FLX Pro Device implant attempt and were discharged between Q4 2023 to Q4 2025.
As appropriate, subgroup analyses may be performed. These analyses may include (but are not limited to) endpoint evaluation for the following subgroups:
• IFU/Indication compliant implants
• Post-implant drug regimens
• Sex/gender
• Race/ethnicity
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| Sample Size |
Data will be captured from all LAAO Registry participating sites in the United States The estimated number of subjects for this study is approximately 30,000
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| Key Study Endpoints |
Safety Endpoints
Primary:
• The occurrence of one of the following events between the time of the first implant procedure and within seven days of the procedure or by hospital discharge, whichever is later:
o All-cause death,
o Ischemic stroke,
o Systemic embolism, or
o 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.
Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are excluded from this endpoint and will be reported separately.
Secondary: Additional analyses will include occurrence of the following endpoints at each LAAO Registry follow-up time points (discharge, 45 days, 6 months, 12 months, and 24 months post-procedure):
• All-cause death
• All stroke
• Ischemic stroke
• Hemorrhagic stroke
• Device-related thrombus (DRT)
• Systemic thromboembolism
• Major bleeding
• Device embolism
These endpoints will be analyzed descriptively.
Effectiveness Endpoints
Primary: The occurrence of ischemic stroke or systemic embolism at 24 months post-implant
Secondary: Additional analyses will include occurrence of the following endpoints at each LAAO Registry follow-up time points (discharge, 45 days, 6 months, 12 months, and 24 months post-procedure):
• Effective device closure
o Note: Effective device closure is measured via LAAO Registry DCF field “Device Margin Residual Leak”. Effective device closure is defined as “Complete Seal” or 0 < Device Margin Residual leak (mm) less than or equal to 5mm.
• Implant success (defined as device release and deployed)
These endpoints will be analyzed descriptively.
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| Follow-up Visits and Length of Follow-up |
The LAAO Registry will collect data at baseline, procedure, discharge, and at follow-up visits: 45 days, 6 months, 12 months, and 24 months post-procedure. Patients will be followed for 2 years.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
Safety Results As of this progress report, the key safety endpoint even rate was 0.20%
(44/21595) in the ITT data set. Similarly, 0.18% (38/20925) of subjects have had 1 or more key safety events in the Implanted data set. DRT occurred in 0.54% (57/10653) of implanted subjects who had a TEE
or CT at 45 days and 1.24% (6/485) at 6 months.
Effectiveness Results
Effectiveness Results Effectiveness endpoint will be measured at 24 months. However, per the "Additional Clinical Endpoints Update," through 45-days of follow-up (14012 patients have reached this endpoint), the adjudicated instances of ischemic stroke (IS) and systemic embolism (SE) are n= 25 (0.115% of the total 21595 ITT). Through 6-months of follow-up (1642 patients have reached this timepoint), the adjudicated instances of IS/SE are n=35 (0.69% of total 21595 ITT). SURPASS Pro subjects are deemed to have successful implants if the procedure was not ‘Aborted’ and the device outcome was ‘Deployed, released’. The SURPASS Pro Implant success rate for the current population is 96.89% (20924/21595). Effective device closure (device margin residual leak <5mm) in subjects with available imaging data was >99% after the procedure, >99% at 45 days and >99% at 6 months.
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| Actual Number of Patients Enrolled |
As of end of Q2 2024, 21595 ITT subjects were enrolled
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| Actual Number of Sites Enrolled |
N/A
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| Patient Follow-up Rate |
Follow-up Rate Subject follow-up is ongoing. The total ITT follow-up rate at 45 days is 67.2% (14428/21472) with 0.53% (114/21472) subjects noted as lost to follow-up. The total Implant follow-up rate at 45 days is 67.3% (14012/20808) with 0.49% (101/20808) subjects noted as lost to follow-up. The total ITT follow-up rate at 6 months is 12.2% (1642/13448); this visit has not occurred yet for 74.6%
(10030/13448) of eligible subjects. The total Implant follow-up rate at 6 months is 12.4% (1617/12989); this visit has not occurred yet for 74.7% (9706/12989) of eligible subjects.
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