Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— SMARTER-VT  

Official title:

Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913375
• Other study ID #: KB/430-77/23
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: May 2026

Study information

• Verified date: June 2023
• Source: Maria Sklodowska-Curie National Research Institute of Oncology
• Contact: Slawomir Blamek, MD, PhD, MBA
• Phone: +48322788052
• Email: slawomir.blamek[@]io.gliwice.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Radiation:
• Stereotactic Body Radiotherapy
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch	Gliwice
Poland	Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia	Katowice

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology	Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the treatment	Number of patients with a reduction of the number of ventricular tachycardia (VT) episodes by at least 50% within 6 months after the irradiation compared to the number of VT episodes within 6 months before the intervention (based on registration from ICD/CRT-D), including: the number of high-energy discharges; number of low-energy discharges for VT that was treated with stereotactic radiotherapy (STAR)	6 months
Secondary	Six-month survival without VT episodes		6 months
Secondary	Number of patients with complete elimination of ICD discharges		12 months
Secondary	Number of patients with a 90% reduction in the number of ICD discharges		12 months
Secondary	Number of hospitalizations due to VT episodes		12 months
Secondary	Recurrences outside the irradiated area	Number of patients who developed VT with a different morphology than specified during qualification for the procedure	12 months
Secondary	Early treatment safety	Number of serious adverse events (SAE) in the first 3 months after the intervention	3 months
Secondary	Long term treatment safety	Number of SAE episodes within 12 months after the intervention	12 months
Secondary	Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.	Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and	12 months
Secondary	Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up		12 months
Secondary	Change in the need for antiarrhythmic drugs		12 months
Secondary	Evaluation of changes in the left ventricular ejection fraction		12 months
Secondary	Evaluation of changes in the morphology of the heart in the ultrasound examination		12 months
Secondary	Assessment of compliance of the results of additional imaging with the results of EAM	Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)	3 months