Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial

NCT06990139 | Active Not Recruiting

• 1 other identifier: 0001344/24
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia (VT)

Keywords

ventricular tachycardia; radioablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in antiarrhythmic drug burden compared to the baseline

  36 months

• Change in left ventricular end-diastolic volume compared to the baseline

  36 months

• Change in left ventricular end-systolic volume compared to the baseline

  36 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Rome, ROME, 00168, Italy

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 25, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: May 25, 2025

Record last verified: 2025-04

Locations

IT (1)