Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies
Jazyk angličtina Země Velká Británie, Anglie Médium print
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
Grantová podpora
Adagio Medical Inc
PubMed
38582974
PubMed Central
PMC10998960
DOI
10.1093/europace/euae076
PII: 7641150
Knihovny.cz E-zdroje
- Klíčová slova
- Ablation, Clinical trial, Cryoablation, Outcomes, Ultra-low, Ventricular tachycardia,
- MeSH
- jizva komplikace MeSH
- kardiomyopatie * komplikace diagnóza chirurgie MeSH
- katetrizační ablace * škodlivé účinky MeSH
- komorová tachykardie * diagnóza etiologie chirurgie MeSH
- kryochirurgie * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- senioři MeSH
- teplota MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
AIMS: The ultra-low-temperature cryoablation (ULTC) ablation system using -196°C N2 cryogen has been reported to create lesions with freeze duration-dependent depth titratable to over 10 mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evaluating the safety and efficacy of a novel, purpose-built ULTC catheter in endocardial ablation of scar-dependent ventricular tachycardias (VTs). METHODS AND RESULTS: This prospective, multi-centre study enrolled patients referred for de novo or second ablations of recurrent monomorphic VT of both ischaemic and non-ischaemic aetiologies. Primary safety and efficacy endpoints of the study were freedom from device- or procedure-related major adverse events (MAEs) up to 30 days post-ablation, acute non-inducibility of clinical VTs at the end of the procedure, and freedom from sustained VT or implantable defibrillator intervention at 6 months. Ultra-low-temperature cryoablation was performed in 64 patients (age 67 ± 11 years, 78% ischaemic, ejection fraction = 35 ± 10%) at 9 centres. The primary acute effectiveness endpoint was achieved in 94% (51/54) of patients in whom post-ablation induction was attempted. There were no protocol-defined MAEs; four procedure-related serious adverse events resolved without clinical sequelae. At 6-month follow-up, 38 patients (60.3%) remained VT-free, and freedom from defibrillator shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts. In 47 patients with defibrillator for at least 6 months prior to the ablation, the VT burden was reduced from median of 4, inter-quartile range (IQR, 1-9) to 0, IQR (0-2). CONCLUSION: In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients with both ischaemic-cardiomyopathy and non-ischaemic-cardiomyopathy. CLINICAL TRIAL REGISTRATION: NCT04893317.
Adagio Medical Inc Laguna Hills CA USA
Bordeaux University Hospital IHU LIRYC University of Bordeaux Bordeaux France
Cardiovascular Center OLV Hospital Moorselbaan 164 9300 Aalst Belgium
Department for Internal Medicine University Hospital Halle Halle Germany
Department of Cardiology Na Homolce Hospital Prague Czech Republic
Department of Cardiology St Antonius Hospital Nieuwegein The Netherlands
Department of Electrophysiology Leipzig Heart Center Leipzig Germany
Department of Medicine Montreal Heart Institute Montreal QC Canada
Helmsley Electrophysiology Center Mount Sinai Fuster Heart Hospital New York NY USA
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ClinicalTrials.gov
NCT04893317