Clinical trial NCT06922214: VT ART Consortium: Radioablation for Ventricular Tachycardia
Official title: VT-ART-P: Ventricular Tachycardia Ablation and RadioTherapy, a Prospective Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia (VT)
Keywords: Radioablation
Ventricular Tachycardia
STAR
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.

Detailed description: By agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. At that visit,

* 12-lead ECG will be performed
* Echocardiography
* CT scan of the chest
* Laboratory tests: NT proBNP, HS Troponin I
* PMK device evaluation The study will have a duration of 60 months and will involve 52 patients with the same disease from which one is affected. Specifically, the total expected duration of individual subject participation in the study will be 60 months.

Participation in the study does not involve any expense for the patient or any compensation.

Participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus.

The following benefits can be expected from participation in this study: reduction of VT episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : LVEF, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, RVEF and TAPSE for right ventricular function, improvement of patient's quality of life (SF-36) compared to baseline. No direct benefits may also emerge from the study, but still significant for research.

Eligibility criteria: Inclusion Criteria:

1. Patients with refractory VT
2. age \> 18 years
3. Patients with ICDs for follow-up
4. Ineligible for heart transplantation.
5. Prognosis of not less than 1 year
6. Ability to express autonomous consent to therapies or (in case of inability due to clinical condition) deferred consent (first indicated by the referring clinician, later expressed by the patient once recovered to autonomous condition

Exclusion Criteria:

1. Evaluation of ICD demonstrating polymorphic VT;
2. Patients with INTERMACS class greater than 4;
3. Patients with LVAD;
4. Patients with active neoplastic disease undergoing oncological treatment.

Primary outcomes:
measure: Change in the number of VT episodes
timeFrame: Starting from the week after treatment until 6 months later
Secondary outcomes:
measure: Change in patient management
timeFrame: Starting from the week after treatment until 6 months later
measure: Change in the dosage of antiarrhythmic drugs
timeFrame: Starting from the week after treatment until 6 months later
measure: Change in cardiac parameters
timeFrame: Starting from the week after treatment until 6 months later
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli IRCSS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Francesco Cellini
role: PRINCIPAL_INVESTIGATOR
References: