Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

Maria Sklodowska-Curie National Research Institute of Oncology11 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventricular Tachycardia

Interventions

Cardiac RadiosurgeryRADIATION

Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch

Gliwice, Silesian Voivodeship, Poland

Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice

Katowice, Poland

Outcomes

Primary Outcomes

Acute toxicity evaluated using CTCAE v5.0 scale

The study aims to demonstrate the safety of the treatment method defined as 3-month observation without Grade III or higher adverse events in at least 6 out of 7 patients (1st stage), and in total in at least 9 out of 11 patients (2nd stage) with an interim safety analysis after obtaining data on primary outcome in first 7 patients.

Time frame: 3 months

Secondary Outcomes

Efficacy of the treatment

Reduction of VT burden, ICD shocks and improvement in life quality as described by SF-36 (The Short Form Health Survey) v2 questionnaire. f eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

Time frame: 24 months

Biochemical markers of cardiac injury

Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) to assess the early cardiac muscle damage and changes in severity of congestive heart failure.

Time frame: 24 months

Late toxicity and mortality

Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death.

Time frame: 24 months

Anti-arrhythmic drugs uptake

Changes in the anti-arrhythmic medications over time after treatment.

Time frame: 24 months

Cardiac injury

Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies.

Data from ClinicalTrials.gov

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