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

NCT ID: NCT05913375

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2026-05-31

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.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiotherapy

Intervention Type: RADIATION

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

Interventions

Stereotactic Body Radiotherapy

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

Intervention Type: RADIATION

Other Intervention Names

Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland

UNKNOWN

Sponsor Role: collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sławomir Blamek, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

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

Wojciech Wojakwoski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Marcin Miszczyk, MD, PhD

Role: STUDY_CHAIR

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

Locations

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

Gliwice, , Poland

Site Status: RECRUITING

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

Katowice, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Sławomir Blamek, MD, PhD, MBA

Role: CONTACT

slawomir.blamek@io.gliwice.pl

+48322788052

Marcin Miszczyk, MD, PhD

Role: CONTACT

marcin.miszczyk@io.gliwice.pl

Facility Contacts

Sławomir Blamek, MD, PhD, MBA

Role: primary

slawomir.blamek@io.gliwice.pl

+48322788052

Marcin Miszczyk, MD, PhD

Role: backup

marcin.miszczyk@io.gliwice.pl

Wojciech Wojakowski, MD, PhD

Role: primary

welwetek@poczta.onet.pl

Tomasz Jadczyk, MD, PhD

Role: backup

tomasz.jadczyk@gmail.com

Other Identifiers

KB/430-77/23

Identifier Type: -

Identifier Source: org_study_id