VT ART Consortium: Radioablation for Ventricular Tachycardia (VT-ART-P)

VT-ART-P: Ventricular Tachycardia Ablation and RadioTherapy, a Prospective Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventricular Tachycardia (VT)
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00168
      • Policlinico Universitario Agostino Gemelli IRCSS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Refractory ventricular tachycardia patients; Patients with refractory VT as defined above; age > 18 years; ICD patients for follow-up; Not eligible for heart transplantation.; Prognosis not less than 1 year. They will have an initial assessment to verify that condition met the inclusion criteria required for participation, such as.It will be performed; 12-lead ECG; Echocardiography; CT scan of the chest; Laboratory analysis: NT proBNP, HS Troponin I; PMK device evaluation and clinical ECG storage. They will undergo stereotactic treatment on the arrhythmogenic cardiac site

Radiation: Stereotactic Body Radiation Therapy (SBRT); SBRT ( 25 Gy single fractions at isodose 80%) on the area responsible of ventricular tachicardia; Other Names: Ventricular Radioablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of VT episodes	The primary endpoint will be The reduction in VT episodes compared with the pre-treatment period as reported by ICD assessment at follow-up within 12 months after enrollment. The number of VT episodes during the last 3 months before treatment will be compared with the number of VT episodes recorded in a 3-month period after the 'blanking period' thus during the 4th, 5th and 6th months.	Starting from the week after treatment until 6 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient management	Reduction in VT episodes compared with the pre-treatment period as reported by ICD query in the shortest observational period. In more detail: the number of VT episodes in the last month before treatment will be compared with the number of VT episodes recorded in the third (3rd) month after treatment.	Starting from the week after treatment until 6 months later
Change in the dosage of antiarrhythmic drugs	Total reduction/suspension of antiarrhythmic drugs compared with baseline (before radiotherapy).	Starting from the week after treatment until 6 months later
Change in cardiac parameters	Improvement in cardiac parameters compared with baseline: LVEF, left ventricular diastolic volume	Starting from the week after treatment until 6 months later

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Francesco Cellini, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Radioablation; Ventricular Tachycardia; STAR
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 0001221/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No