Is pulse field ablation approved and readily available?

[Johnnyk1000]

I am reading the PFA could be the holy grail of ablations for Afib. However I’m not clear on if it’s generally available. Any insights?

[mjames1]

Still only in trial in the States where I'm from, but my understanding it has clearance in Europe and available in selected centers. Don't know if it's the "holy grail" but it certainly has peaked my interest and seems an improvement over current offerings.

Jim

[gerickson021 in reply to mjames1]

Hi Jim, do you know where in France? I have decided to travel if I need a second to get a PF. I am also cash pay and cash pay here in the US is $50,000, absurd.

[mjames1 in reply to gerickson021]

Let me check to see if I can figure out where. Are you in the US? As far as I know, you cannot get pulse field in the US for any amount of money unless you're enrolled in a trial.

JIm

[gerickson021 in reply to mjames1]

Thanks, I am not legible for trial so will have to go Germany or France. Having trouble finding clinics with PF but if you have a source please let me know.

Greg

[mjames1 in reply to gerickson021]

I thought I had some notes but could not find them. I would try "google" for older PFA trials in Europe and then contact the trial doctors. If I find anything sooner I will let you know. If you find anything, please let me know.

Jim

[MummyLuv in reply to gerickson021]

The leading light in catheter ablation (as they invented it) is the Bordeaux Clinic in France. They also offer pulsefield I am pretty sure. They spoke about pulsefield at last year’s stopafib conference.

guardheart.ern-net.eu/ern-g...

I considered going there before deciding on a mini maze. Best of luck!

[MummyLuv in reply to MummyLuv]

Yes they have been doing it at the Bordeaux clinic for over a year.

ihu-liryc.fr/en/news/b/firs...

[gerickson021 in reply to MummyLuv]

Thanks!

[MummyLuv in reply to gerickson021]

Good luck, would love to hear how you get on

[JoseT]

It is very promising because it looks very safe as is tissue-selective and also it seems a successful PVI ablation might not regress over time as it happens with the previous technologies. I had myself the ablation done few days ago in Czech Republic (Farapulse catheter - farapulse.com/us/home#af-ab... and lasted less than 90 minutes. In the US is still in trial. As far as i know in Europe is already adopted in few countries like Germany, Austria or Czechia. The technology can only be used for PVI as there is no point-to-point catheter available yet.

[mjames1 in reply to JoseT]

Thanks Jose for the information. Please keep us updated on your progress. As far as "only be used for PVI" I was told by a pulse field trial nurse that they will treat point to point during the same procedure if needed, for example on the right side. I thought she meant via pulse field but perhaps it was with rf. Or maybe it was with a competing pulse field technology to farapulse.

Jim

[BobD Volunteer]

So many things have been such since my journey began. Like new drugs, then come, they go they come back again.

[sotolol]

I would go on the list if it was.

[Singwell]

My EP told me that they're waiting to see how others do with it. That's QEH Birmingham where they have 3 EPs. I understand Dr Tim Betts at Radcliffe Oxford is doing it. Because it uses a sonic force to destroy the rogue cells it causes less tissue damage in the heart is my understanding. I'm.sure it will become more the norm here in time.

[secondtry]

Thanks for posting, gone into my 'Ablation' file for future consultation as necessary. Have a great day!

[Kingdaddy]

In the US, it's still under clinical trial. As I understand it, there are a couple of different approaches for it as well. One is the Faraday Pulsed Field catheter, which you can see here: farapulse.com/us/home.

The other is the Affera solution with its HD mapping approach; there's a great video of it on their homepage here: affera.com/

I was in a clinical trial for it last month. The interesting part of the Affera technogy is that the same catheter can switch between pulsed field and radio frequency ablation, and if you're lucky enough to get this technology in the trial, they actually use both - they use Pulsed Field for posterior wall solution, and radio frequency for pulmonary vein isolation.

Details about the clinical trial are available here: clinicaltrials.gov/ct2/show...

They are still accepting patients that qualify. Inclusion criteria is listed on the link above.

[Johnnyk1000]

Thank you for that info. How are you doing post ablation? And what would be my first steps to apply for the clinical trial? Who do I call? I’m very interested.

[theohappy in reply to Johnnyk1000]

Hi, Johnny, I believe in the US they began trials with qualifying patients who had PAF. Now they are conducting trials for patients with persistent AF. I was going to participate in the latter a couple of weeks ago. But for personal reasons decided against it. You are in the trial for a year. After that time they will let you know which ablation you received. Either the PFA or the standard RF ablation. It is a 50/50 shot at getting the PFA. Keep in mind they don't give these trials to just any hospital or EP. So whatever you get it is going to be at an excellent facility with an outstanding EP. Had my life circumstances been different, I definitely would have gone for it! I am including the contact information for the one I was going to do. They will go over with you all the criteria and details. My EP believes the PFA is very promising! And, hopes it will be FDA approved within the next couple of years. The best part about is nothing touches the heart, no burning, no freezing. That's a huge win!

Contact Info:

Violet Trevino, CRC Texas Cardiac Arrhythmia Research Foundation

3000 N. IH-35 Ste 705 Austin, TX 78705

Office [phone] x 1838 Fax [phone]

tcaheart.com/research-studies/