AUTHOR=Cellini Francesco , Narducci Maria Lucia , Pavone Chiara , Bencardino Gianluigi , Perna Francesco , Pinnacchio Gaetano , Chiesa Silvia , Massaccesi Mariangela , Gambacorta Maria Antonietta , Manfrida Stefania , Longo Silvia , Mannocci Alice , Di Gregorio Giuseppe , Boldrini Luca , Tagliaferri Luca , Indovina Luca , Placidi Lorenzo , Stimato Gerardina , Spera Francesco Raffaele , Scacciavillani Roberto , Crea Filippo , Valentini Vincenzo , Pelargonio Gemma 

TITLE=Ventricular tachycardia ablation through radiation therapy (VT-ART) consortium: Concept description of an observational multicentric trial via matched pair analysis

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 10 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1020966

DOI=10.3389/fcvm.2023.1020966

ISSN=2297-055X

ABSTRACT=Monomorphic ventricular tachycardia (VT) is a life-threatening condition often observed in patients with structural heart disease. Ventricular tachycardia ablation through radiation therapy (VT-ART) for sustained monomorphic ventricular tachycardia seems promising, effective, and safe. VT-ART delivers focused, high-dose radiation, usually in a single fraction of 25 Gy, allowing ablation of VT by inducing myocardial scars. The procedure is fully non-invasive; therefore, it can be easily performed in patients with contraindications to invasive ablation procedures. Definitive data are lacking, and no direct comparison with standard procedures is available. The aim of this multicenter observational study is to evaluate the efficacy and safety of VT-ART, comparing the clinical outcome of patients undergone to VT-ART to patients not having received such procedure. The two groups will not be collected by direct, prospective accrual to avoid randomization among the innovative and traditional arm: a retrospective selection through matched pair analysis will collect patients presenting features similar to the ones undergone to VT-ART within the consortium (in each center independently). Our trial will enroll patients with optimized medical therapy in whom endocardial and/or epicardial radiofrequency ablation (RFA), the gold standard for VT ablation, is either unfeasible or fails to control VT recurrence. Our primary outcome is investigating the difference in overall cardiovascular survival among the group undergoing to VT-ART and the one not exposed to the innovative procedure. Secondary outcome is evaluating the difference in ventricular event free survival after the last procedure (i.e.: last RFA versus VT-ART) between the 2 groups. Additional secondary aim is to evaluate the reduction in number of VT episodes comparing the three months before procedure to the ones recorded at six months (from fourth to sixth month) following VT-ART and RFA, respectively. Other secondary objectives include: identify the benefits of VT-ART on cardiac function, as evaluated through electrocardiogram, echocardiographic, biochemical variables, and on patient quality of life. 
We calculated the sample size (in a 2:1 ratio) upon enrolling 149 patients: 100 in the non-exposed control group and 49 in the VT-ART group.