Fellow Pulse field ablation pals

[Jmbrph]

I’m interested in talking to others who’ve had a pulse field ablation , had mine over a year ago and SO happy that I had it as part of a clinical trial . How soon before FDA approves pulse field ablation in the U.S. ?

[saulger]

This, from March 2022:

"Recently, the Food and Drug Administration (FDA) approved the device for ablation in patients with paroxysmal and persistent atrial fibrillation (AF) after its safety and efficacy had been demonstrated in 4 controlled prospective trials: IMPULSE, PEFCAT, PEFCAT-2, and PersAFone."

ncbi.nlm.nih.gov/pmc/articl....

[MummyLuv]

wonderful to read, this has such a promising future 🤞😍

[Kingdaddy]

I received PFA in May 2022 in the Aferra clinical trial at the Cleveland Clinic for persistent AFIB. The Affera Sphere 9 catheter does both PFA and RFA, and they did PFA on the pulmonary veins and used RFA on the posterior wall, one right after the other with the same catheter. Pretty amazing. I've been in NSA since.

That trial doesn't end until November, 2023, and then they will have to report the results to the FDA for analysis/approval. So their technology is not approved yet. But I believe PFA will be the gold standard for cardioablation in the US once approved.

This is the trial: clinicaltrials.gov/ct2/show...