Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 149 people enrolled
- Started
- 30 Mar 2025
- Expected to end
- 30 Mar 2029
- Type of study
- Observational, 2 groups
- Record updated
- 25 May 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Patients with active neoplastic disease under oncological treatment
- ICD interrogation demonstrating polymorphic VT
- Patients with INTERMACS class more than 4
- Patients with LVADs
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- 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
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial Via Matched Pair Analysis (VT-ARTr)
- Record updated
- 25 May 2025