Study design
The PINNACLE FLX study, a single-arm, non-randomized trial at 29 U.S. sites with 400 patients, assessed the WATCHMAN FLX Device for non-inferiority in safety and efficacy against performance goals for the Legacy WATCHMAN™ LAAC Device.
- Follow-up: 45 days (+TEE), 6 months, 12 months (+TEE), 18 months, and 24 months
- Patient characteristics: Average CHA2DS2-VASc of 4.2 ± 1.5, Average HAS-BLED of 2.0 ± 1.0
- Post-implant drug regimen: Non-vitamin K antagonist oral anticoagulant/acetylsalicylic acid (NOAC/ASA) for 45 days, Clopidogrel/ASA to 6 months, ASA post 6 months
- Primary safety endpoint: All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within seven days following the procedure, or by hospital discharge, whichever is later.
- Primary efficacy endpoint: The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months
- Secondary efficacy endpoint: The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
- Inclusion/exclusion criteria is consistent with Legacy WATCHMAN Device clinical study inclusion/exclusion criteria. Patients must be eligible for short-term NOAC vs warfarin in previous clinical studies.
Advanced safety3
Proven safe outcomes
The low 0.5% event rate demonstrates the enhanced safety profile of the WATCHMAN FLX Device, and shows a statistically significant difference to the performance goal set for similar safety endpoints, in the PREVAIL Trial and CAP2 Registry.*
Ischemic stroke rate
(2/400)
All-cause death rate
Rate of pericardial
effusions requiring
open cardiac surgery
Device embolization rate
TOTAL
major adverse
event rate*1
Primary safety endpoint met
* Based on the combined rate observed in PREVAIL(3) and CAP2(4), plus a clinically acceptable delta.
Adverse event rate comparison
1. Holmes, DR. et al. (2014). J AM Coll Cardiol 64(1): 1-12
2. Holmes, DR et al. JACC 2019
* PREVAIL(3) and CAP2(4) studied the Legacy WATCHMAN LAAC Device
** Occurrence of one of the following events between the time of implant and within seven days following 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.
Advanced procedural performance3
Proven efficacy outcomes
The WATCHMAN FLX Device is designed to enhance left atrial appendage (LAA) closure, as demonstrated by a 100% rate of effective LAA closure, at 12 months.*
Primary efficacy endpoint met
thrombus (12-months)
at 12-month follow-up
* LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed transesophageal echocardiogram (TEE).
† Performance goal based on the rates observed in PREVAIL(3) and CAP2(4), minus a clinically-relevant delta.
Expand the treatable patient population3
Designed to treat the widest range of patient anatomies
Non-vitamin K antagonist oral anticoagulant (NOAC) discontinuation
>96% of patients discontinued OAC after 45 days*
| Study/OAC | % Discontinuation |
|---|---|
| PINNACLE FLX/NOAC. | 96.2% |
| PREVAIL/warfarin1 | 92% |
| CAP2/warfarin2 | 93% |
Broader range of anatomies†
6.6% of enrolled patients in PINNACLE FLX were previous WATCHMAN screen fails or case aborts, and 97% of those patients were successfully implanted with WATCHMAN FLX.4
Procedure performance
99% of patients successfully implanted (395/400)*1
* Procedure success defined as successful delivery and release of a WATCHMAN FLX Device into the LAA.
† Measured maximum LAA ostium width and/or deployed closure device diameter must be ≥ 14.0 mm and ≤ 31.5 mm to accommodate available Closure Device sizes. LAA depth should be approximately half of the labeled implant diameter, or longer.
‡ This figure includes both the main cohort, and roll-in patients, totaling 452 implants.
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References
1. Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
2. Holmes, DR., et al, JACC 2019.
3. Kar S, et al. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021;143:1754-1762.
4. Ellis et al. Presented at AF Symposium 2020.