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

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

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Radiation: Cardiac Radiosurgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Katowice, Poland
    • Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
  • Śląskie
    • Gliwice, Śląskie, Poland, 44-102
      • Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Radiosurgery; 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.	Radiation: Cardiac Radiosurgery; Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.; Other Names: Stereotactic Arrhythmia Radioablation (STAR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 months
Late toxicity and mortality	Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death.	24 months
Anti-arrhythmic drugs uptake	Changes in the anti-arrhythmic medications over time after treatment.	24 months
Cardiac injury	Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies.	24 months
Target volume delineation	Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods)	24 months

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Investigators: Principal Investigator: Sławomir Blamek, dr hab. n. med., Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO); Principal Investigator: Wojciech Wojakowski, prof. dr hab. n. med., Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice; Study Chair: Marcin Miszczyk, dr n. med., Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Ablation; Stereotactic Body Radiation Therapy; Ventricular Tachycardia; Radiosurgery; Noninvasive; Substrate Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: SMART-VT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data will be shared within the European STOPSTORM consortium, which is dedicated to the development of cardiac radiosurgery for the treatment of ventricular tachycardia. The intention to share anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No