Adagio Medical has announced its first pulsed field cryoablation (PFCA) procedure performed using the Adagio CryoPulse catheter system as part of the PARALELL (Pulsed field ablation and pulsed field cryoabLation in perrsistent atriaL fibriLlation) clinical trial.
The procedure was performed at St Antonius Hospital Nieuwegein (Nieuwegein, The Netherlands) by Lucas Boersma (Amsterdam UMC, Amersterdam, The Netherlands) co-principal investigator of the trial.
“PFCA is a unique ablation modality consisting of a 30-second ultra-low temperature cryoablation (ULTC) cycle with pulsed field ablation (PFA) delivered at the very end of the cycle using a single catheter system,” said Boersma. “The recent trial of ULTC established a new benchmark of ablation effectiveness in persistent AF with reported 85% freedom from AF after a single procedure, and the PARALELL trial will test the performance of PFCA against that benchmark, with additional benefit of shorter ablation times. In addition, the trial design allows for randomisation of patients to PFCA or PFA, delivered by the same catheter to create identical sets of lesions with similar characteristics.”
“PFA has recently captured the attention of the electrophysiology community with the expectation of achieving safer and faster procedures based on the selective effect on the myocardium as compared to currently dominant point-by-point radiofrequency ablations, and multiple PFA systems are currently undergoing clinical evaluations,” said Atul Verma (McGill University Health Centre, Montreal, Canada) PARALELL co-principal investigator and a world-renowned expert in PFA. “Physiologically, PFCA builds on the tissue selectivity of PFA by focusing electrical fields into a target myocardial tissue, pre-treated by short-duration ULTC to increase lesion depth and ensure transmurality, and by forming the isolating layer of ice between the electrodes and the blood. As a result, microbubble showers, phrenic nerve capture and muscle contractions observed in traditional PFA are effectively eliminated. So, in effect, we are taking advantage of the benefits of ULTC and PFA collectively, while minimising their individual disadvantages.”
The ablation procedures in the PARALELL trial will be performed using the first generation of Adagio’s CryoPulse PFCA catheter in combination with proprietary PFA and iCLAS cryoablation consoles. The iCLAS cryoablation system for treatment of paroxysmal and persistent AF as well as atrial flutter received CE mark and is commercial in Europe.
The safety and effectiveness of the iCLAS system for the treatment of persistent AF are being evaluated in an US Food and Drug Administration (FDA) investigational device exemption (IDE) trial in the US. The Adagio Medical clinical trials portfolio also includes the Cryocure-VT trial which is evaluating safety and performance of the vCLAS ULTC catheter system for treatment of monomorphic ventricular tachycardias.