How to Get in on PFA Trials?

Is there any particular approach to get in on a Pulsed Field Ablation trial? Carey kindly provided this list of trials. I'm in Canada, so the one I'm most interested in is the one at McGill. I've tried to go through the phone system, but no luck. I tried emailing the kardium email adress provided, but no reply. Is there some particular channel you go through to get in on a trial? Any suggestions?

Thanks!

Call the EP dept.at McGill and determine who the principal investigating EP is for the study. Contact that EP and request an appointment virtual or in person, send all pertinent medical records to their office ahead of the appointment. Purpose of the appointment: to be evaluated for treatment for AFIB and indicate your interest in being enrolled in the Globe Pulse field Study. They’re maybe a quicker process, but this is what I did in order to get enrolled in the AdMire PFA study. Current status from clinical trials.gov indicates that this site is not yet recruiting; I believe this would be a good time to get in touch with them.

Good Luck

Steve

Thanks Steve, I'll give this a try again next week.

I have flutter as well as aFib, what are the chances one of these studies would do more for participants than just the PVI?

If I were to go to the US, I'm assuming it would be out of pocket. Or, given it's a study, is the fee covered do you think? I've heard some medical trials actually pay perticipants...

I am not aware of any PFA trial that pays participants; they may pay for data submissions during the trial period. Out of pocket costs? Check with your insurance carrier.

If the hospital conducting the study sponsored ablations has an EP research department you might try reaching out their first for enrollment guidance

Hello SailorGuyI,

I tried to get on a trial for PFA here in NYC, but my EP said I was not a good candidate, I think the trail had closed already.
My friend at my gym did have the PFA at Mount Sinai in November, she is doing great, because it was a trail she did not know what she was having PFA, RF, or cryo. She found out later it was PFA, she is older with persistent AFIB.
As I had nine episodes of AFib n April, I decided to go ahead and do a Cryo ablation. My brother who is a medical physicist advised me to do it now, as it could take two years before PFA is approved. The cryo ablation was textbook except for the zero energy and fatigue. Not much good as a first mate on a boat right now.

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SamIAm
If I were to go to the US, I'm assuming it would be out of pocket. Or, given it's a study, is the fee covered do you think? I've heard some medical trials actually pay perticipants...

No one's going to pay you, but the sponsor of the trial is probably a PFA device manufacturer, and they should pick up all the costs. It shouldn't cost you more than travel expenses, and they might even help with some of that. I got my Watchman as part of a trial, and Boston Scientific paid all the costs except travel, but they did reimburse me for mileage to/from the airport and parking. So my total cost was plane ticket,. meals, and two nights in a hotel. My insurance company never even knew I had it done.

Aoife5, did they ever say why you weren't a good candidate? Interesting about not knowing what treatment she would get, though I don't think the study I'm looking at is like that... Do you know if your friend got just the PVI or did they work on other parts of the heart too?

I'm going to do what I can to get into the McGill trial. But if that doesn't work out, it might be a ways to wait. I just read an article now that said PFA was expected to be approved end of this year but now is expected mid 2024. Maybe it might be worth it for me to look in Europe given it will be out of pockect for me in the US anyway (Canada will probably be years away before it being readily available, so not a great option...).

With 9 episodes in a month, Aoife5, I totally see why you would get it done now with cryo. The risks and dammage of afib continuing seem like they would outweight the benefits of a moderately safer procedure in a couple years. I only have episodes when life gets tough, when I take on too much, get sick, or have to deal with a lot of emotional stress. More troublesome are all the ectopics, but I'm told they aren't as risky. I would like to be more robust and do more with my life, but would very much prefer a procedure with less colateral dammage...

That's good to know, Carey, I think that means I shouldn't focus soley on the McGill trial, thanks. I just read about the watchmen now for the first time, sounds promising, so many advancements going on.

Hi SamlAm,

My EP said he would not recommend it for me as I was not persistent, This trial was sponsored by Farapulse from Boston Scientific. I was only diagnosed early February and the trial had closed at the that stage. I had thought about going to Bordeaux, In the following months everything was a trigger, tea, salt, sugar, cold drinks, chocolate, I was walking on egg shells. Nine episodes in April was the deciding factor. My friend at the gym had a successful PVI with PFA.
As I was intermittent, my EP did a Cryo ablation.

I'm sure you have seen this

hds [ PM ]
Pulsed Field Ablation experiences?
June 30, 2023 11:17PM Registered: 2 months ago
Posts: 37
I just got approved for PFA in Amsterdam UMC (University Medical Center). I have a standing appointment for thermal ablation here in the Pacific Northwest, but the risk profile is astoundingly better for PFA and it reaches the same benchmark for success as thermal, which prompted me to make an appointment in Amsterdam