Feasibility study of Ablation vs Sham Ablation

[Halfheart]

This study looks like it will be interesting. The inital feasibility study was encouraging for efficacy of ablation.

sciencedirect.com/science/a...

[BobD Volunteer]

Sounds like stating the ******* obvious to me. Mind you, how to you placebo an ablation.? Presumably they would have to make incision in groin to "pretend "to go into the heart along with all the other holes I have experienced. .

[Jalia in reply to BobD]

Hmm......having had 4 ablations I'm pretty sure I would know if my heart had been tampered with or not..

[mav7 in reply to BobD]

Totally agree, Bob. Definitely stating the obvious. Someone has some grant money to waste. Could be wisely used elsewhere.

[saulger]

The study compares catheter ablation to cardioversion for persistent AFib patients.

Who did you think will win?

This research is a little dated (from 2015) and for persitent AFib patients the success rate of a single CA was just 20.1% and 55.9% for multiple CAs after 5 years. Efficacious?

ahajournals.org/doi/10.1161....

[Threecats in reply to saulger]

That study makes for interesting reading, thank you for posting.

[Halfheart]

The patients were wheeled into the cath lab and had groin sheaths inserted. Once they were under anaesthetic, they were randomised to get cryoablation or cardioversion. If they had the cardioversion, they also got a sham ablation, including the pacing drugs etc. When they came round from the anaesthetic, they were all in sinus rhythm and the staff caring for them had no idea which procedure they had received. The main point of this feasibility study was to see if it was possible to maintain the blinding, and it was.

[Halfheart]

This is the first ever sham procedure study of AF ablation. Nobody can say for certain what the outcome will be, it is unknown and that is why a team led by an EP who does ablations is interested in doing it. Many common medical procedures have been laid low by such trials. See Orbita for example. Also Watchman. Many others. My money would be on a positive outcome for ablation, but you don't know until you do the study.

[sillguy]

cardioversion doesn't last. no point in putting people through this particular thing just to "see if blinding can work."

[Halfheart in reply to sillguy]

Ablations don't last either. How long do people stay in sinus after a cardioversion? 3 months? 6 months? A year? Plenty (the majority?) of single-ablation patients also relapse in that time. This study will make the comparison. Checking the feasibility of blinding was only a goal of the feasibility study, the main study has a bigger goal.

[wilsond]

I'm not sure on the ethics here,did the patients give consent? Were they aware of the trial?If not,very dodgy I'm afraid.

[Halfheart in reply to wilsond]

Well it was done in the UK by St Barts, so I think you should assume they reviewed the ethics. The benefit to the participants was that they would get treated immediately (versus going into a long UK waiting list for an ablation). Even if you were randomized to the cardioversion wing of the trial, you would get an ablation if your afib returned, and this was still likely to get you ablated faster than being on a waiting list outside the trial. So everyone benefited, regardless of which treatment they were initially randomized to. This trial might not be so easy justify in other countries where ablation waiting lists are shorter.