Clinical trial NCT06990139: Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial
Official title: Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial Via Matched Pair Analysis (VT-ARTr)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ventricular Tachycardia (VT)
Keywords: ventricular tachycardia
radioablation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at Fondazione Policlinico Gemelli IRCCS and in all centers that joined the protocol

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.


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

Primary outcomes:
measure: Change in VT episode frequency compared to the pretreatment period
timeFrame: Starting from three months before treatment until 3 months later
Secondary outcomes:
measure: Change in antiarrhythmic drug burden compared to the baseline
timeFrame: 36 months
measure: Change in left ventricular end-diastolic volume compared to the baseline
timeFrame: 36 months
measure: Change in left ventricular end-systolic volume compared to the baseline
timeFrame: 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)
Study officials:
References: