Trial Rationale

5.5 million patients  are affected by  NVAF worldwide

NVAF patients have  a 2-7x greater risk  of ischemic stroke

Current guidelines state that non-vitamin K antagonist oral anticoagulant (NOAC) therapy is the first line option for treatment of stroke risk reduction in non‑valvular atrial fibrillation (NVAF) patients. However, bleeding risk on these therapies compounds year over year, and are comparable across current pharmacotherapy options.

The bleeding risk associated with anticoagulants compounds year over year graph

*The HAS-BLED scoring system predicts a patients risk of major bleeding in patients with atrial fibrillation.
**Assumes constant risk despite increasing age, and bleeding risk is independent from bleeding risk in previous years.

The SIMPLAAFY clinical trial seeks to evaluate two monotherapy regimens as front-line alternatives to dual antiplatelet therapy (DAPT) following LAA closure with the WATCHMAN FLX™ Pro LAAC Device in patients with non-valvular AF.

With this trial, Boston Scientific aims to expand its LAAC clinical leadership through new evidence intended to demonstrate new monotherapy regimens as safe and effective alternatives, leading to more personalized post-implant bleeding risk management strategies.

Why SIMPLAAFY?

Presently labeled peri-procedural antithrombotic regimens, including DAPT, are intended to mitigate the risk of adverse outcomes (e.g. device related thrombus) until the LAAC device endothelializes, however still may carry bleeding risk during the peri-procedural drug period.

SIMPLAAFY is a randomized controlled trial that will evaluate two monotherapy regimens vs. DAPT after implant with the WATCHMAN FLX Pro Device, allowing for assessment of whether a less intensive post-implant drug regimen may help mitigate bleeding risk and provide other viable options for post-implant treatment.

Find a Trial Site

Boston Scientific has selected US sites to be SIMPLAAFY investigational centers. If you have a candidate in mind, view the active trial list provided by clinicaltrials.gov, and reach out to a study physician near you to discuss next steps for referral.

Site Locator

1. Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the u.S. Adult population. The American journal of cardiology. 2013;112:1142-1147
2. Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, et al. Acc/aha/esc 2006 guidelines for the management of patients with atrial fibrillation—executive summary: A report of the american college of cardiology/american heart association task force on practice guidelines and the european society of cardiology committee for practice guidelines (writing committee to revise the 2001 guidelines for the management of patients with atrial fibrillation). J Am Coll Cardiol. 2006;48:854-906
3. Patel, M. NEJM 2011; 365(10): 883-891.
4. Granger, C. NEJM 2011; 365(11): 981-992.
5. Connolly, S. NEJM 2009; 361(12): 1139-1151.
6. Giugliano, R. NEJM 2013; 369(22): 2093-2104.
7. Marzec, et al. JACC 2017: 69(20): 2475-2484.

WATCHMAN FLX Pro Device Brief Summary

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