I attended hospital last week for my final round of testing related to my clinical trial; CEASE-AF, three years and two months after the completion of treatment.
The trial involved a mini-maze followed by a catheter ablation, this was being compared against the outcome of two catheter ablations
Apparently, significantly fewer numbers than expected were recruited (at least in the UK where there were 15 instead of 45) and the completion worldwide has been delayed by Covid (a lot of research effort was diverted to the vaccine). The finish date was originally expected to be November 2020, supposedly the date on which the last subject has their final interview. In July, when the last update was published, it was expected that recruitment of new subjects would take place which could push the trial back another few years.
In spite of this a preliminary analysis is being prepared which may suggest that the trial was overwhelmingly successful, if so, the trial will be stopped and the recommendations published.
My own experience of the trial is now three and a half years without AF, the last three years of which have been drug-free.
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johnMiosh
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Am delighted with the result for you that is so great ! Thank you for sharing . I have bookmarked it you never know when these things will come in handy !
Sounds great! I hope this is something that they can eventually roll out for AF patients. Is it only something that will likely be for those in permanent AF?You must be walking on air!
Permanent AF is when the decision is taken not to restore NSR. This is for persistent AF, where catheter ablation is not as effective as it is for paroxysmal AF. It is not an easy option, the "non-invasive" mini-maze is particularly tough on the body.
Hi Peter, I certainly paid my dues along the canal during my recovery. Back to the hills now, 3000 miles this year, but 1.5 mph slower than I used to be (although this is deliberate, self imposed max HR is now aerobic rather than actual maximum). Get well soon.
Amazing results, John Miosh. I do have a few questions.
I see some locations absent namely North America ( Canada and the U.S. ) as well as France. The participant were Czechoslovakia, Germany, the Netherlands, Poland, and the United Kingdom. Any information on why just these five locations participated?
Among the exclusion criteria was #5: Patient underwent previous ablation procedure or heart surgery. That exclusion would mean that you have had no previous ablation? And, why would previous ablations be excluded?
As a criterion, you were either in persistent AF or in long -standing persistent AF not greater than 10 years. Where did you fall within those parameters?
With the study actually started in November 2015, and actual completion date November 2020, the study becomes a five year period. You say your time period is three years and two months, that would place you about September 2017. Was there any advantage in terms of how the procedure was performed since it had already been done for two years prior to yours?
You also say you are drug free. Do you have any information on how you compare to the others in being drug free?
Congratulations! A remarkable achievement for those that land in long-standing persistent with minimal hope with currently established procedures. The above is not a test. I just got carried away with your brilliant success.
Other than volunteering for the study, I don't have much more information about it, so some of the below is from memory or conjecture.
I don't know why those few areas were chosen, but the study was sponsored by the manufacturers of the atri-clip. I believe this and similar devices are in common use in North America, but not so much in Europe, so that may be the reason.
I had not had a previous ablation. I was diagnosed in Spring 2016, had a barrage of tests in the summer and a cardioversion in the Autumn. I was on the waiting list for ablation when I was contacted about the trial. The study was to compare the outcomes of two treatment types, so anyone who had had an earlier procedure was excluded.
I unknowingly had paroxysmal AF since early 2015 which became persistent in March 2016.
My mini-maze was completed in April 2017, my follow up catheter ablation was supposed to be in July/August, but was delayed until October; so I was reporting on my time since completion, but I have actually pretty much been AF-free since the first procedure 3 years and eight months. Even though I was recruited late into the study I was only the third person to be signed up and I think I was the second to have the mini-maze. The catheter ablation part was done by an experienced EP and would be no different to ablations performed outside the trial. I found a report on mini-maze that showed the experience of a surgeon in the technique did not affect the outcome, but experienced surgeons were able to complete it faster. So I don't believe the time I was accepted onto the trial affected the outcome.
I only met one other study subject; she was selected for two catheter ablations, but further complications were found and she did not complete. The research nurse told me that the mini-maze group were all doing very well, but the catheter group were generally still on medication.
I am very happy with the outcome, I was so lucky that this was available at the time I needed it. I have to say that the mini-maze was difficult, and I was a relatively fit and young AF sufferer. I said at the time that I felt like I had been hit by a truck, and that I would need to see evidence of the effectiveness of the approach before I recommended it to anyone else. It looks like that may be coming soon.
I have reported at length on HU, if you are interested check out my posts. For an even longer and tedious read try afibandcycling.wordpress.com/
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