As many of you know, I have long argued (unsuccessfully until now) for a placebo-controlled trial of AF ablation. One group gets the ablation; the other gets a placebo or sham procedure. This way we can sort out the placebo-resistant effect of the ablation.
Finally, here is the first report of one.
Dr. Malcolm Finlay is an electrophysiologist at St Bartholomew hospital in London UK and primary investigator of the study. They recently published their feasibility study for AF ablation vs placebo.
The American Heart Journal published the pilot study of 20 patients.
Finlay and colleagues call it the ORBITA AF trial. But it’s important to note that this was done separate from the ORBITA investigators at Imperial College. The larger study will have a different name.
Here is a copy and paste:
Twenty patients with PersAF (duration <2years) were recruited, representing 10% of the proposed larger trial as determined by a power calculation. The patients were randomized in a 1:1 ratio to receive either PVI±DCCV(PVI group) or DCCV+Placebo(DCCV group).
The primary endpoint was to evaluate the blinding of the patients.
The good news is that it mostly worked. Blinding was successful in most patients. Recurrence of AF was less in the ablation vs cardioversion arm. But the numbers were too small to say much. Same with quality of life measures, which were mostly similar until 12 months.
The authors concluded that
This feasibility study establishes the potential for conducting a blinded, placebo-controlled trial to evaluate the efficacy of PVI versus DCCV in patients with PersAF.
I hope you enjoy the conversation.
This is darn exciting for the field.
And I am delighted to publish this conversation on Sensible Medicine. (I also tried to include the un-edited transcript of the conversation.)
A discussion with the primary investigator of the world's first placebo-controlled AF ablation trial