History of Changes for Study: NCT05913375

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

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Study Record Versions

Version	Submitted Date	Changes
1	June 13, 2023	None (earliest Version on record)
2	June 21, 2023	Sponsor/Collaborators, Conditions and Study Status
3	October 18, 2023	Recruitment Status, Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	KB/430-77/23
Brief Title:	Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia (SMARTER-VT)
Official Title:	Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Secondary IDs:

Study Status


Record Verification:	June 2023
Overall Status:	Not yet recruiting
Study Start:	June 2023
Primary Completion:	May 2026 [Anticipated]
Study Completion:	May 2026 [Anticipated]

First Submitted:	June 13, 2023
First Submitted that Met QC Criteria:	June 13, 2023
First Posted:	June 22, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	June 13, 2023
Last Update Posted:	June 22, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Maria Sklodowska-Curie National Research Institute of Oncology
Responsible Party:	Sponsor
Collaborators:	Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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:

Conditions


Conditions:	Ventricular Tachycardia
Keywords:	ventricular tachycardia, radiosurgery, radioablation, stereotactic arrhythmia radioablation (STAR), stereotactic body radiotherapy (SBRT)

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	20 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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.	Radiation: Stereotactic Body Radiotherapy Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM) Other Names: Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery

Outcome Measures


Primary Outcome Measures:
1.	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)
Secondary Outcome Measures:
1.	Six-month survival without VT episodes [ Time Frame: 6 months ]
2.	Number of patients with complete elimination of ICD discharges [ Time Frame: 12 months ]
3.	Number of patients with a 90% reduction in the number of ICD discharges [ Time Frame: 12 months ]
4.	Number of hospitalizations due to VT episodes [ Time Frame: 12 months ]
5.	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
6.	Early treatment safety [ Time Frame: 3 months ] Number of serious adverse events (SAE) in the first 3 months after the intervention
7.	Long term treatment safety [ Time Frame: 12 months ] Number of SAE episodes within 12 months after the intervention
8.	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
9.	Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up [ Time Frame: 12 months ]
10.	Change in the need for antiarrhythmic drugs [ Time Frame: 12 months ]
11.	Evaluation of changes in the left ventricular ejection fraction [ Time Frame: 12 months ]
12.	Evaluation of changes in the morphology of the heart in the ultrasound examination [ Time Frame: 12 months ]
13.	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)

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Sławomir Blamek, MD, PhD, MBA Telephone: +48322788052 Email: slawomir.blamek@io.gliwice.pl
Central Contact Backup:	Marcin Miszczyk, MD, PhD Email: marcin.miszczyk@io.gliwice.pl
Study Officials:	Sławomir Blamek, MD, PhD, MBA Principal Investigator Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
	Wojciech Wojakwoski, MD, PhD Principal Investigator Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice
	Marcin Miszczyk, MD, PhD Study Chair Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Locations:	Poland
	Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch Gliwice, Poland, 44-102 Contact:Contact: Sławomir Blamek, MD, PhD, MBA +48322788052 slawomir.blamek@io.gliwice.pl Contact:Contact: Marcin Miszczyk, MD, PhD marcin.miszczyk@io.gliwice.pl
	Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia Katowice, Poland, 40-635 Contact:Contact: Wojciech Wojakowski, MD, PhD welwetek@poczta.onet.pl Contact:Contact: Tomasz Jadczyk, MD, PhD tomasz.jadczyk@gmail.com

IPDSharing


Plan to Share IPD:	Yes 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 Information: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
	Time Frame:
	Access Criteria:
	URL:

References


Citations:
Links:
Available IPD/Information: