Wait for PFA trial or go for regular ablation?

I've been debating bringing this up to the group, but I would appreciate the feedback, especially from Carey and Shannon, plus all the wise regulars on this forrum. But first, I want to wish you all kinds of well, Susan. May your new home bring you joy.

I changed my health insurance this year in order to have Dr. Natale do an ablation, which would be my first 'procedure'. Communications with his team in Austin have been great and I'm scheduled for 3rd wk in April, UNLESS his May trial for Pulsed Field Ablations will be for those who have FLUTTER, which I developed last summer. (Until then my afib was 'mild' as I would describe it, and I'd take a low dose of beta blocker as needed, which wasn't often).
I was told by Natale's research person that he would let me know by the end of this month (March) whether the trial would be one in which I could participate, but even with an email sent to him 5 days ago, I've yet to hear back. (Shannon, do you have any way to know Natale's 'PFA trials info?). I realize I should feel fine with Natale doing a regular ablation for me, but in my limited knowledge, I think that being a participant in a PFA trial is a preference as it has less potential side effects. And that once one has a regular ablation, it closes a door to be a participant in a PFA trial. --I'd appreciate any comments...

The other question I have for this qroup is about potassium intake.I have powdered potassium and single 99 mg caps. I take the small capsules with meals but for some reason am scared (illogically) to take larger doses of the powdered potassium through the day. My kidney's are fine. Since I started adding the 99 mg capsules (2 to 3/day), I think it works with my magnesium and is a benefit. I realize humans are supposed to get over 4,000 mg of potassium a day but for some reason can't shake my fear of adding larger doses of potassium to my daily intake. (And yes, I read and re-read Patrick Chambers' article on Magnesium and Potassium in LAF...).

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californiagal
I changed my health insurance this year in order to have Dr. Natale do an ablation, which would be my first 'procedure'. Communications with his team in Austin have been great and I'm scheduled for 3rd wk in April, UNLESS his May trial for Pulsed Field Ablations will be for those who have FLUTTER, which I developed last summer. (Until then my afib was 'mild' as I would describe it, and I'd take a low dose of beta blocker as needed, which wasn't often).
I was told by Natale's research person that he would let me know by the end of this month (March) whether the trial would be one in which I could participate, but even with an email sent to him 5 days ago, I've yet to hear back. (Shannon, do you have any way to know Natale's 'PFA trials info?). I realize I should feel fine with Natale doing a regular ablation for me, but in my limited knowledge, I think that being a participant in a PFA trial is a preference as it has less potential side effects. And that once one has a regular ablation, it closes a door to be a participant in a PFA trial. --I'd appreciate any comments...

My comment is it depends on how your afib/flutter is impacting you. I get the impression that there is a material impact, which would argue for sooner rather than later.

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californiagal
The other question I have for this group is about potassium intake.I have powdered potassium and single 99 mg caps. I take the small capsules with meals but for some reason am scared (illogically) to take larger doses of the powdered potassium through the day. My kidney's are fine. Since I started adding the 99 mg capsules (2 to 3/day), I think it works with my magnesium and is a benefit. .

"If hyperkalemia comes on suddenly and you have very high levels of potassium, you may feel heart palpitations, shortness of breath, chest pain, nausea, or vomiting. Sudden or severe hyperkalemia is a life-threatening condition. " Source

My suggestion (since you say your kidneys are healthy) would be to slowly increase your dose and see if you notice anything concerning. If you want to get sciency about it, you could spend some money using direct to consumer lab testing. These are 3rd party resellers of Quest & Labcorp tests (you buy a test through the company, they give you a lab order that you print out and take & get your blood drawn, then results come to you in your email. In my experience, New Century Labs is the cheapest, but you can go to my first link, where there are a bunch of options and price it out. You could get a test, take say 1/2 tsp (1 gram of K) of the powder, wait an hour & retest. Most afibbers find that a serum level of at least 4, maybe 4.5 mmol/L is best & you'd not like it to be over 5.0. There was a point in time where some folks here (including Shannon & Carey) used a Cardy agricultural potassium meter to test saliva. There is a way to convert those results to serum levels. They will tell you that if you take serum potassium in a bolus (a lot at one time), it will get excreted by healthy kidneys very fast. I've take up to 8-10 grams as a bolus without any negative consequences. I generally take 4 g/day over the day by dissolving it in a liter of water & drinking it periodically during the day. As I write this, I'm traveling to attend a destination wedding. I managed to forget my water bottle. Am staying in a room with a partial kitchen, so measured out a liter of water into a cooking pan. I put 2 tsp potassium as potassium citrate along with 1/2 tsp sea salt & mixed it up. Will consume over the day.



Edited 3 time(s). Last edit at 04/03/2023 08:21PM by GeorgeN.

Many thanks George, on both questions. My conversation with the research person in Austin this morning indicates that the FDA nationwide study might not happen until June or July, so I'm leaning towards going ahead with the regular ablation with Natale this April..

Hello California. Who did you talk to at the research team. Was it Seun? He is a nice guy and very helpful. I DM'ed you on this as well. I haven't been on the site for some time.

My PFA was cancelled and postponed until the next time. I thought it would happen in May but upon reading your post, it appears it will be in June/July? Did Seun confirm those are the dates they are looking at?

john

Yes, John. Seun said the national FDA pulsed field ablation trials have been moved to late June or July.

A family member with AFib needs an ablation and is very interested the PFA procedure. We are aware that although PFA catheter systems by Medtronic and Boston Scientific have been approved for use in Europe, no PFA devices have yet been approved by the FDA for use in the U.S. We are looking for a clinical trial that my AFibber could possibly join. There is a PFA study listed on ClinicalTrials.gov that includes St. David’s in Austin, where Dr. Andrea Natale practices, as one of the locations, but the study is described as completed as of 3/13/23. Dr. Atul Verma is the lead researcher, and the results are reported in a 3/8/23 article entitled Pulsed Field Afib Ablation Hits Endpoints in Pivotal Trial. Apparently the study tested the Medtronic devices. Does anyone know of any other trials with U.S. locations that may be in the recruitment phase?

Did you try Dr Reddy’s trials at Mt. Sinai Hospital in Manhattan? He was doing trials.

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Rothko
PFA study listed on ClinicalTrials.gov that includes St. David’s in Austin, where Dr. Andrea Natale
practices, as one of the locations, but the study is described as completed as of 3/13/23

The trial that californiagal above is looking at is with Dr. Natale at St. David’s in June/July. You might want to call their research department.

Thanks. I had not heard of Dr. Reddy's trial. I will follow up.

Thanks. I will.

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Rothko
Thanks. I had not heard of Dr. Reddy's trial. I will follow up.

[reports.mountsinai.org]

Seems like they will continue with 2023 trials

“ Following this successful first-in-human study, there are active plans to commence a multicenter, multinational FDA trial in early 2023; Mount Sinai will be the lead site for this clinical trial, with Dr. Reddy serving as the overall trial Principal Investigator.”



Edited 1 time(s). Last edit at 04/18/2023 03:49AM by susan.d.

Thanks susan.d & Daisy for your helpful information. As of 4/20/23 ClinicalTrials.gov lists only 1 PFA study in the U.S. that is currently recruiting participants: A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation (ADVANTAGE AF), in which Dr. Vivek Reddy at Mt. Sinai is a principal investigator. A second study (Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation (PULSAR)) is underway internationally, with Mt. Sinai as its only U.S. site, but Mt. Sinai is not yet recruiting. I have phoned & emailed the relevant contact people to ask how a person can become a participant, but have not yet had a response.

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Rothko
Thanks susan.d & Daisy for your helpful information. As of 4/20/23 ClinicalTrials.gov lists only 1 PFA study in the U.S. that is currently recruiting participants: A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation (ADVANTAGE AF), in which Dr. Vivek Reddy at Mt. Sinai is a principal investigator. A second study (Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation (PULSAR)) is underway internationally, with Mt. Sinai as its only U.S. site, but Mt. Sinai is not yet recruiting. I have phoned & emailed the relevant contact people to ask how a person can become a participant, but have not yet had a response.

Check your PM.

I have.paroxysmal and would be very interested in being a part of that study. If anyone has success in contacting them I would love to hear from you.