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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
RECRUITING
Gliwice
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
RECRUITING
Katowice
Contact Information
Primary
Sławomir Blamek, MD, PhD, MBA
slawomir.blamek@io.gliwice.pl
+48322788052
Backup
Marcin Miszczyk, MD, PhD
marcin.miszczyk@io.gliwice.pl
Time Frame
Start Date: 2023-07-24
Estimated Completion Date: 2026-05
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
Leads: Maria Sklodowska-Curie National Research Institute of Oncology

This content was sourced from clinicaltrials.gov