Clinical trial NCT04642963: Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
Official title: Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Ventricular Tachycardia
Ablation
Noninvasive
Stereotactic Body Radiation Therapy
Radiosurgery
Substrate Ablation
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acute toxicity evaluated using CTCAE v5.0 scale
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy of the treatment
timeFrame: 24 months
measure: Biochemical markers of cardiac injury
timeFrame: 24 months
measure: Late toxicity and mortality
timeFrame: 24 months
measure: Anti-arrhythmic drugs uptake
timeFrame: 24 months
measure: Cardiac injury
timeFrame: 24 months
measure: Target volume delineation
timeFrame: 24 months
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch
state: Śląskie
Study officials:
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
name: Sławomir Blamek, dr hab. n. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
name: Wojciech Wojakowski, prof. dr hab. n. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
name: Marcin Miszczyk, dr n. med.
role: STUDY_CHAIR
References: