CT scan of the brain, showing a prior right-sided ischemic stroke from blockage of an artery. Credit: INFARCT.

Boston Scientific has begun the CHAMPION-AF clinical trial to analyse the safety and efficacy of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device for patients suffering from non-valvular atrial fibrillation (NVAF).

Such patient population includes those who are at low-to-moderate risk of bleeding from anticoagulation use.

The WATCHMAN FLX LAAC device will be compared to treatment with non-vitamin K antagonist oral anticoagulants (NOACs), which are considered to be contemporary drugs for stroke risk reduction in this population.

Approximately 33 million people across the world suffer from atrial fibrillation (AF), a common heart rhythm disorder, which makes people suffering with this condition five times more likely to have a stroke than those with a normal heart rhythm. 

In patients suffering with NVAF, over 90% of heart-related blood clots form in the left atrial appendage.

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The device was designed to permanently close off this area of the heart, offering a one-time solution for those requiring an alternative to anticoagulation to reduce the risk of a stroke.

The randomised CHAMPION-AF trial will see the enrolment of 3,000 patients with NVAF.

Such patients are suitable for oral anticoagulation therapy across a broad spectrum of stroke and bleeding risk.

During the trial, patients at approximately 150 global sites will be randomised to receive the latest-generation WATCHMAN FLX device or a NOAC and they will be followed for five years.

The study will evaluate the rates of stroke, systemic embolism, cardiovascular death,  and post-procedural major or clinically relevant non-major bleeding.

Boston Scientific global chief medical officer Dr Ian Meredith said: “The CHAMPION-AF trial will compare the WATCHMAN FLX device in a head-to-head fashion against best-in-class pharmacological therapy for stroke prevention and evaluate the technology as first-line therapy for those who can tolerate anticoagulation.

“A positive outcome for this study has the potential to change clinical practice and expand device access to more patients who would benefit from a one-time procedural alternative to the long-term use of blood thinners and their potential side effects, including those patients at low-to-moderate bleeding risk.”

According to the company, the trial will add to the body of clinical proof for the WATCHMAN FLX device, along with PINNACLE FLX and the currently enrolling OPTION trial, which is a randomised controlled trial comparing the device to oral anticoagulants, including but not limited to NOACs in patients, suffering from non-valvular AF, who also undergo a cardiac ablation procedure.