aMAZE Trial

I am still not understanding all of this.

There is a clinical trial, the aMAZE Trial (https://clinicaltrials.gov/ct2/show/NCT02513797), that uses a device called the Lariat to electrically isolate the LAA in those with persistent and longstanding persistent afib having catheter ablation. The study is expected to be completed in December, with results reported soon after that.

Is this the LAA isolation/ablation that Dr. Natale does? If so, and the trial ends in December and the results of the trial will come after that, how does one know the outcome of this procedure at this time?

If it would be recommended by Dr. Natale that I get this procedure, it makes me very anxious because it is still in the clinical trial phase. Hopefully folks on this site can help me understand this.....the stroke risk and the fact that not all EPs recommend it is what still causes me to have the stress,

Thanks for your patience!!

The Lariat has been around quite a while (FDA approved in 2006), so this isn't a trial of a new device. This is comparing using the Lariat prior to a standard PVI ablation vs. just doing the PVI alone. I think there's a very good chance the trial will improve success rates of the PVI because isolating the LAA is key to solving persistent afib in many patients.

To my knowledge Natale does not use the Lariat. It requires a surgical procedure.

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Carey
To my knowledge Natale does not use the Lariat. It requires a surgical procedure.

Invasive open heart/breaking ribs surgical procedure right?

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susan.d
Invasive open heart/breaking ribs surgical procedure right?

No, I think you're thinking of the AtriClip. That can be done during open heart surgery or also by minimally invasive methods (but "minimally invasive" is used loosely here -- it involves opening several holes in your chest).

The Lariat is truly a minimally invasive procedure. They insert two catheters: one under your rib cage that carries the device, and the second through your femoral vein just like in an ablation. The second catheter is sent to your LAA and used to guide the first catheter into place.