NCT05913375

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 19, 2023

Status Verified

June 1, 2023

Enrollment Period

2.8 years

First QC Date

June 13, 2023

Last Update Submit

October 18, 2023

Conditions

Ventricular Tachycardia

Keywords

radioablationstereotactic arrhythmia radioablation (STAR)stereotactic body radiotherapy (SBRT)ventricular tachycardia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Six-month survival without VT episodes

    6 months

  • Number of patients with complete elimination of ICD discharges

    12 months

  • Number of patients with a 90% reduction in the number of ICD discharges

    12 months

  • Number of hospitalizations due to VT episodes

    12 months

  • Recurrences outside the irradiated area

    12 months

  • +8 more secondary outcomes

Study Arms (1)

Cardiac radioablation

EXPERIMENTAL

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

Interventions

Stereotactic Body RadiotherapyRADIATION

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

Also known as: Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery
Cardiac radioablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Gliwice, 44-102, Poland

RECRUITING

Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia

Katowice, 40-635, Poland

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Marcin Miszczyk, MD, PhD

    Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

    STUDY CHAIR

Central Study Contacts

Sławomir Blamek, MD, PhD, MBA

CONTACT

+48322788052slawomir.blamek@io.gliwice.pl

Marcin Miszczyk, MD, PhD

CONTACT

marcin.miszczyk@io.gliwice.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 22, 2023

Study Start

July 24, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

October 19, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

PL(2)