Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial (VT-ART R)

Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial Via Matched Pair Analysis (VT-ARTr)

Recurrent ventricular tachycardia (VT) is a potentially life-threatening arrhythmia in patients with structural heart disease. Despite the use of antiarrhythmic drugs, implantable cardioverter-defibrillators (ICDs), and radiofrequency catheter ablation, VT recurrence rates remain high-reaching up to 66% in some series. For patients with refractory VT who are not candidates for further ablation or surgical interventions, there is a significant unmet need for novel, effective, and non-invasive treatment options.

Stereotactic body radiation therapy (SBRT) has recently emerged as a promising approach for treating ventricular arrhythmias through a technique known as stereotactic arrhythmia radioablation (STAR). Preliminary studies, including a phase I/II clinical trial, have demonstrated a substantial reduction in VT burden-up to 99.9%-following treatment, with an acceptable safety profile. Reported adverse events have included manageable pericardial effusion, radiation-induced pericarditis, and pneumonitis. The growing body of evidence supports STAR as a feasible and effective alternative for selected patients with treatment-resistant VT.

The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy as a non-invasive ablation technique for the treatment of ventricular tachycardia (VT) in patients with refractory arrhythmias in whom conventional therapies have failed.

This is a retrospective observational study aimed at comparing outcomes between patients who received stereotactic radioablation and those who did not. A matched-pair analysis will be used to adjust for baseline clinical characteristics and ensure comparability between groups.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventricular Tachycardia (VT)

• Study Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at Fondazione Policlinico Gemelli IRCCS and in all centers that joined the protocol

Description

Inclusion Criteria:

• Diagnosis of refractory ventricular tachycardia (VT), as previously defined
• Age greater than 18 years
• Presence of an implantable cardioverter-defibrillator (ICD) for follow-up
• Not eligible for heart transplantation
• Estimated life expectancy of at least 1 year
• Ability to provide autonomous, informed consent to participate in the study

Exclusion Criteria:

• ICD interrogation demonstrating polymorphic VT
• Patients with INTERMACS class more than 4
• Patients with LVADs
• Patients with active neoplastic disease under oncological treatment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients who have undergone SBRT; Within this group we find patients who have had all possible canonical treatments for the arrhythmia and also the stereotactic radiation treatment
patients who have not undergone SBRT; Within this group we find patients who have had all possible canonical treatments for the arrhythmia, but not the stereotactic radiation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VT episode frequency compared to the pretreatment period	The number of VT episodes during the 3 months prior to treatment will be compared to the number of episodes recorded during the 3-month period following the post-treatment blanking period. This comparison will help determine whether the treatment provides clinical benefits even at an early stage	Starting from three months before treatment until 3 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in antiarrhythmic drug burden compared to the baseline	The study aims to show whether radioablation treatment is associated with a significant reduction in the use of antiarrhythmic drugs compared to patients who did not undergo the procedure	36 months
Change in left ventricular end-diastolic volume compared to the baseline	Improvement in left ventricular end-diastolic volume, as assessed through specific tests performed by a cardiologist specializing in arrhythmology, especially the Echocardiogram, and a global electrophysiological evaluation	36 months
Change in left ventricular end-systolic volume compared to the baseline	Improvement in left ventricular end-systolic volume , as assessed through specific tests performed by a cardiologist specializing in arrhythmology , especially the Echocardiogram, and a global electrophysiological evaluation	36 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: May 19, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: ventricular tachycardia; radioablation
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 0001344/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No