Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

NCT ID: NCT04642963

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2023-01-10

Brief Summary

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

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.

Conditions

Ventricular Tachycardia

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Cardiac Radiosurgery

Intervention Type: RADIATION

Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.

Interventions

Cardiac Radiosurgery

Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.

Intervention Type: RADIATION

Other Intervention Names

Stereotactic Arrhythmia Radioablation (STAR)

Eligibility Criteria

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

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

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Slawomir Blamek

dr hab. n. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sławomir Blamek, dr hab. n. med.

Role: PRINCIPAL_INVESTIGATOR

Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)

Wojciech Wojakowski, prof. dr hab. n. med.

Role: PRINCIPAL_INVESTIGATOR

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

Marcin Miszczyk, dr n. med.

Role: STUDY_CHAIR

Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)

Locations

Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch

Gliwice, Silesian Voivodeship, Poland

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

Katowice, , Poland

Countries

Poland

Other Identifiers

SMART-VT

Identifier Type: -

Identifier Source: org_study_id