Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT)

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Completed

Conditions: Ventricular Tachycardia

Treatments: Radiation: Cardiac Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04642963

SMART-VT

Details and patient eligibility

About

Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).

Full description

The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaining popularity in scientific literature as a viable alternative to salvage catheter ablations. Considering the scarcity of data from prospective trials and concern about the safety of the treatment method, this trial seeks to determine whether Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT) meets the expected safety requirements for clinical use.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
• Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment.
• At least one episode of monomorphic VT registered in electrophysiological examination.
• Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment).
• Patient must be able to understand and be willing to sign a written informed consent document.

Exclusion criteria

• Heart failure requiring inotropic treatment or mechanical assistance
• Arrhythmia due to cardiac channelopathy
• Reversible source of arrhythmia
• NYHA (New York Heart Association) stage IV hearth failure
• Hearth infarction or cardiac surgery in last 3 months
• Life expectancy <6 months
• Polymorphic VT
• Pregnancy
• Prior radiotherapy to the thoracic region (relative contraindication)
• Failure to induce VT during electrophysiological examination

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

Cardiac Radiosurgery

Experimental group

Description:

Patients with ventricular tachycardia will undergo a non-invasive cardiac radiosurgery using one fraction of 25 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping.

Treatment:

Radiation: Cardiac Radiosurgery