Clinical trial NCT05913375: Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Official title: Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: radioablation
stereotactic arrhythmia radioablation (STAR)
stereotactic body radiotherapy (SBRT)
ventricular tachycardia
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
First posted: 2023-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the treatment
timeFrame: 6 months
Secondary outcomes:
measure: Six-month survival without VT episodes
timeFrame: 6 months
measure: Number of patients with complete elimination of ICD discharges
timeFrame: 12 months
measure: Number of patients with a 90% reduction in the number of ICD discharges
timeFrame: 12 months
measure: Number of hospitalizations due to VT episodes
timeFrame: 12 months
measure: Recurrences outside the irradiated area
timeFrame: 12 months
measure: Early treatment safety
timeFrame: 3 months
measure: Long term treatment safety
timeFrame: 12 months
measure: Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.
timeFrame: 12 months
measure: Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up
timeFrame: 12 months
measure: Change in the need for antiarrhythmic drugs
timeFrame: 12 months
measure: Evaluation of changes in the left ventricular ejection fraction
timeFrame: 12 months
measure: Evaluation of changes in the morphology of the heart in the ultrasound examination
timeFrame: 12 months
measure: Assessment of compliance of the results of additional imaging with the results of EAM
timeFrame: 3 months
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
city: Katowice
country: Poland
facility: Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
Study officials:
affiliation: Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
name: Sławomir Blamek, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice
name: Wojciech Wojakwoski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
name: Marcin Miszczyk, MD, PhD
role: STUDY_CHAIR
References: