Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia (SMARTER-VT)

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Enrolling

Conditions: Ventricular Tachycardia

Treatments: Radiation: Stereotactic Body Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05913375

KB/430-77/23

Details and patient eligibility

About

Prospective single-arm study investigating the efficacy and safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT) with reduced dose of radiation (20 Gy). The efficacy and safety outcome measures will be compared with historical control - patients treated within the SMART-VT study (NCT04642963) with a single dose of 25 Gy to test the hypothesis that reduced dose of radiation is similarly effective in terms of reduction of VT burden.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Patients with structural heart disease
• Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D)
• Clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month
• At least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination
• Recurrent VT despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect).
• Persistent recurrence of VT despite adequate pharmacotherapy.
• Informed consent of the patient to participate in the study.

Exclusion criteria

• Premature ventricular contractions
• Cardiac damage requiring inotropic treatment
• Implantation of left ventricular assist device (LVAD)
• Ventricular arrhythmia in the course of channelopathy
• Reversible cause of VT
• New York Heart Association (NYHA) stage IV heart failure
• Myocardial infarction or cardiac surgery in the last 3 months.
• Life expectancy less than 6 months
• Polymorphic ventricular tachycardia
• Pregnancy or breastfeeding
• Substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments).
• Evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). Patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study.
• Active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation.
• Lack of the informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cardiac radioablation

Experimental group

Description:

Patients with ventricular tachycardia will undergo cardiac radiosurgery with one fraction of 20 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping.

Treatment:

Radiation: Stereotactic Body Radiotherapy