{"doi":"10.1093/europace/euae076","title":"Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies","abstract":"<jats:title>Abstract</jats:title>\n               <jats:sec>\n                  <jats:title>Aims</jats:title>\n                  <jats:p>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).</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results</jats:title>\n                  <jats:p>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).</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion</jats:title>\n                  <jats:p>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.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trial Registration</jats:title>\n                  <jats:p>NCT04893317.</jats:p>\n               </jats:sec>","journal":"Europace","year":2024,"id":639919,"datarank":0.4636563680037475,"base_score":3.091042453358316,"endowment":3.091042453358316,"self_citation_contribution":0.4636563680037475,"citation_network_contribution":0.0,"self_endowment_contribution":0.4636563680037475,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":21,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1662959,"name":"Vidal Essebag","orcid":"0000-0003-0107-5197","position":1,"is_corresponding":false},{"id":748804,"name":"Petr Neužil","orcid":"0000-0003-4334-8165","position":2,"is_corresponding":false},{"id":1662960,"name":"Katia Dyrda","orcid":"0000-0002-0171-9311","position":3,"is_corresponding":false},{"id":1662961,"name":"Jippe Balt","orcid":"0000-0002-7880-3730","position":4,"is_corresponding":false},{"id":1662962,"name":"Borislav Dinov","orcid":"0000-0003-1104-8491","position":5,"is_corresponding":false},{"id":1662963,"name":"Angeliki Darma","orcid":"0000-0003-4756-2775","position":6,"is_corresponding":false},{"id":1662964,"name":"Arash Arya","orcid":"0009-0005-7610-9314","position":7,"is_corresponding":false},{"id":411760,"name":"Frédéric Sacher","orcid":"0000-0001-8348-9320","position":8,"is_corresponding":false},{"id":610800,"name":"Vivek Y. Reddy","orcid":"0000-0002-5638-4993","position":9,"is_corresponding":false},{"id":1662965,"name":"Lucas Boersma","orcid":"0000-0003-4591-4220","position":10,"is_corresponding":false},{"id":1662966,"name":"Ilya Grigorov","orcid":null,"position":11,"is_corresponding":false},{"id":1201276,"name":"Tom De Potter","orcid":"0000-0003-1424-114X","position":12,"is_corresponding":false},{"id":344531,"name":"Atul Verma","orcid":"0000-0002-1020-9727","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies","abstract":"<jats:title>Abstract</jats:title>\n               <jats:sec>\n                  <jats:title>Aims</jats:title>\n                  <jats:p>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).</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results</jats:title>\n                  <jats:p>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).</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion</jats:title>\n                  <jats:p>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.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trial Registration</jats:title>\n                  <jats:p>NCT04893317.</jats:p>\n               </jats:sec>","is_dataset_classified":null,"base_score":3.091042453358316,"endowment":3.091042453358316,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"38582974","pmcid":"PMC10998960","openalex_id":"https://openalex.org/W4394064433","authors":[],"funders":[{"funder_name":"Adagio Medical Inc","grant_id":"","title":null},{"funder_name":"Adagio Medical Inc","grant_id":"","title":null}],"total_grants":2,"fwci":6.2183,"citation_percentile":0.97274829,"influential_citations":0,"citation_trend":[{"year":2024,"count":6},{"year":2025,"count":6},{"year":2026,"count":9}],"oa_status":"hybrid","license":"cc-by","oa_locations":[{"url":"https://academic.oup.com/europace/article-pdf/26/4/euae076/57165032/euae076.pdf","host_type":"journal"},{"url":"https://academic.oup.com/europace/article-pdf/26/4/euae076/57165032/euae076.pdf","host_type":"publisher"},{"url":"https://academic.oup.com/europace/article-pdf/26/4/euae076/57346117/euae076.pdf","host_type":"publisher"},{"url":"https://doi.org/10.1093/europace/euae076","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/38582974","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/10998960","host_type":"repository"},{"url":"https://pure.amsterdamumc.nl/en/publications/9fa60d76-bc1b-43db-8627-043d7a025ede","host_type":"repository"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10998960/pdf/euae076.pdf","host_type":"repository"},{"url":"https://pure.amsterdamumc.nl/ws/files/139997914/Cryocure-vt.pdf","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC10998960","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC10998960?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["Cardiac Arrhythmias and Treatments","Atrial Fibrillation Management and Outcomes","Pain Management and Treatment","Aged","Humans","Middle Aged","Cardiomyopathies","Catheter Ablation","Cicatrix","Cryosurgery","Prospective Studies","Tachycardia, Ventricular","Temperature","Treatment Outcome"],"mesh_terms":["Aged","Cicatrix","Cryosurgery","Humans","Middle Aged","Cardiomyopathies","Prospective Studies","Temperature","Treatment Outcome","Catheter Ablation","Tachycardia, Ventricular"],"keywords":["Medicine","Cryoablation","Ventricular tachycardia","Cardiology","Ablation","Internal medicine","Catheter ablation","Ejection fraction","Clinical endpoint","Cryosurgery","Implantable cardioverter-defibrillator","Tachycardia","Surgery","Clinical trial","Heart failure","Outcomes","Ultra-low"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Peace, Justice and strong institutions"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[{"name":"nct"}],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-07T04:31:10.397119Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}