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Having suffered through 8 months of paroxysmal AF with weekly episodes (not well controlled by medication) prior to undergoing an ablation which has provided a period of 15 months with no episodes of AF plus ability to be medication free, it seems impossible that you could fake an ablation procedure and produce the results I was fortunate enough to receive. I wear a watch that will alert me if I do go into AF so there is independent confirmation of my results. Plus I will continue to undergo halter monitoring for one week every 6 months for a period of two years. That is due to being part of a study on getting FDA approval for the type of ablation that was performed. It’s not all subjective that my quality of life has improved given I have a monitor to confirm the AF is now controlled without medication.

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This sounds like exactly the type of study we need to assess the effectiveness of a given treatment vs. placebo. My only question is why quality of life measures are included. Aren't these somewhat subjective and , therefore, the very essence of the placebo effect? Am I correct in thinking he said that he had a 100% success rate in cardioverting patients with persistent atrial fibrillation?

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The core reason we do AF ablation is to improve quality of life (subjective)

The reason why the placebo control is so important is that in the past all trials have compared a group who gets a big procedure vs a group that does not.

CV is 100% successful *initially* -- the question is how often AF returns (more than after ablation) but does that affect quality of life. Which is exactly why you need a blinded procedure arm.

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Thank you for responding to my questions. Perhaps I didn't state them very clearly. I understand that everything we do in medicine is aimed at improving the quality (and quantity) of life. But the key question here is whether ablation produces a more significant reduction in recurrent AF than cardioversion and conventional medical therapy. It is interesting to note that a sham procedure produces improvement in sense of well being much like sham knee surgery can reduce pain; but why complicate the study with subjective feelings which have no bearing on the main question?

On the question of 100% CV success: I have been retired for some time now and can recall some patients with AF that would not convert. I am curious about whether there might be some changes in the procedure that have brought about the 100% rate.

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Ablation is nowhere near the efficacy of Cox Maze or the minimally invasive variations of Cox Maze? Why is that a surprise when a long catheter is drawing a simple figure on a blurry moving target?

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This is absolutely brilliant. Kudos to this UK EP and his team. And this can be traced back to the Imperial College group who had the temerity to do Orbita 1. It is the scientific rebuttal to any proponent of anything who engages in handwaving that “this intervention will obviously be beneficial cuz of biologic plausibility”.

I think it’s doubly important the lead investigator is an enthusiastic “ablater”. It is noteworthy that even such a proponent has the humility to want to know what the real effect of his treatment is. This should serve as a cognitive (and moral) model for the proponents of anything. If you submit your “thingy” works, prove it (in a properly blinded and placebo resistant fashion).

I’m no EP. But I presume it will mostly be cryo and PFA in this study, since RF can take so long. If a subject was in the lab for 6 hrs, it would be pretty obvious to the blinded staff as to what procedure they got. But also on that basis, I presume there won’t be much posterior wall ablation being done (but I am well beyond my depth here). Alas, this study won’t answer everything, but it should answer more than has ever been answered before.

I’m not usually a podcast person, but this was important enough for me to grab my earbuds. Still, appreciate Dr. Mandrola putting up a transcript. Thanks.

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My husband would have made a good study. Rare form of WPW

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Really appreciate your calls for "scientific" (evidence-based) medicine John! 👏 To quote Phillip K. Dick:

"Reality is that which, when you stop believing in it, doesn't go away".

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