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

NCT ID: NCT06990139

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-30
• Study Completion Date: 2029-03-30

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)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

CELLINI FRANCESCO

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Rome, ROME, Italy

Countries

Italy

Other Identifiers

0001344/24

Identifier Type: -

Identifier Source: org_study_id