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

• ClinicalTrials.gov Identifier: NCT05913375
• Recruitment Status: Recruiting
• First Posted: June 22, 2023
• Last Update Posted: October 19, 2023
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborator: Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
• Information provided by (Responsible Party): Maria Sklodowska-Curie National Research Institute of Oncology

Tracking Information

• First Submitted Date: June 13, 2023
• First Posted Date: June 22, 2023
• Last Update Posted Date: October 19, 2023
• Actual Study Start Date: July 24, 2023
• Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 13, 2023)

Efficacy of the treatment [ Time Frame: 6 months ]

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 13, 2023)

• Six-month survival without VT episodes [ Time Frame: 6 months ]
• Number of patients with complete elimination of ICD discharges [ Time Frame: 12 months ]
• Number of patients with a 90% reduction in the number of ICD discharges [ Time Frame: 12 months ]
• Number of hospitalizations due to VT episodes [ Time Frame: 12 months ]
• Recurrences outside the irradiated area [ Time Frame: 12 months ]
  Number of patients who developed VT with a different morphology than specified during qualification for the procedure
• Early treatment safety [ Time Frame: 3 months ]
  Number of serious adverse events (SAE) in the first 3 months after the intervention
• Long term treatment safety [ Time Frame: 12 months ]
  Number of SAE episodes within 12 months after the intervention
• Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage. [ Time Frame: 12 months ]
  Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and
• Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up [ Time Frame: 12 months ]
• Change in the need for antiarrhythmic drugs [ Time Frame: 12 months ]
• Evaluation of changes in the left ventricular ejection fraction [ Time Frame: 12 months ]
• Evaluation of changes in the morphology of the heart in the ultrasound examination [ Time Frame: 12 months ]
• Assessment of compliance of the results of additional imaging with the results of EAM [ Time Frame: 3 months ]
  Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ventricular Tachycardia

Intervention

Radiation: Stereotactic Body Radiotherapy

Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)

Other Name: Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery

Study Arms

Experimental: Cardiac radioablation

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.

Intervention: Radiation: Stereotactic Body Radiotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 13, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2026
• Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sławomir Blamek, MD, PhD, MBA; +48322788052; slawomir.blamek@io.gliwice.pl

Contact: Marcin Miszczyk, MD, PhD; marcin.miszczyk@io.gliwice.pl

• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT05913375
• Other Study ID Numbers: KB/430-77/23
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The data will be shared within the European Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM). The intention to share the anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)

• Current Responsible Party: Maria Sklodowska-Curie National Research Institute of Oncology
• Original Responsible Party: Same as current
• Current Study Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Original Study Sponsor: Same as current
• Collaborators: Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland

Investigators

• Principal Investigator: Sławomir Blamek, MD, PhD, MBA; Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
• Principal Investigator: Wojciech Wojakwoski, MD, PhD; Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice
• Study Chair: Marcin Miszczyk, MD, PhD; Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

• PRS Account: Maria Sklodowska-Curie National Research Institute of Oncology
• Verification Date: June 2023