Clinical trial NCT06411392: SBRT for Ventricular Arrhythmia
Official title: Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Arrythmia
Keywords: stereotactic radiotherapy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 10
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: The aim of this study is to demonstrate the safety and efficacy of STAR (Stereotactic Antiarrhythmic Radiotherapy) in patients with VT (ventricular tachycardia) who are unresponsive to standard treatments. Additionally, the planned study aims to provide further insights into the effects of STAR on VT burden, ICD interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.


Eligibility criteria: Inclusion Criteria:

* Recurrent VTs/VES with significant burden despite guideline-directed therapy
* Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications
* AND lack of response or intolerance to antiarrhythmic medication
* AND status post ≥1 catheter ablation due to monomorphic VT(s) and VT early recurrence (\<12 months after the last catheter ablation) OR contraindication for endocardial ablation (mechanical valve prosthesis, LV (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate)
* MINIMAL VT BURDEN: The patient must have had at least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months prior to study enrollment.
* Presence of suitability for radiation therapy with respect to SBRT
* Age ≥ 18 years
* Existing informed consent

Exclusion Criteria:

* Acute myocardial infarction or percutaneous coronary intervention or heart surgery (\<3 months before study enrollment)
* Status post intra-thoracic pre-radiation
* Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer
* Advanced symptomatic heart failure (NYHA Class IV)
* Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation)
* Extensive myocardial scar substrate that would result in too large of a radiation volume
* Life expectancy \< 6 months considering all comorbidities and in the Seattle Heart Failure Model
* Presence of a Left Ventricular Assist Device (LVAD)
* Use of cytotoxic medications
* Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential

Primary outcomes:
measure: Safety of treatment
timeFrame: 30 days
measure: Efficacy of treatment
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of changes in the left ventricular ejection fraction
timeFrame: 12 months
measure: Evaluation of mortality
timeFrame: 12 months
measure: Assessment of late side effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References:
citation: Volpato G, Compagnucci P, Cipolletta L, Parisi Q, Valeri Y, Carboni L, Giovagnoni A, Dello Russo A, Casella M. Safety and Efficacy of Stereotactic Arrhythmia Radioablation for the Treatment of Ventricular Tachycardia: A Systematic Review. Front Cardiovasc Med. 2022 Aug 22;9:870001. doi: 10.3389/fcvm.2022.870001. eCollection 2022.
citation: Belzile-Dugas E, Eisenberg MJ. Radiation-Induced Cardiovascular Disease: Review of an Underrecognized Pathology. J Am Heart Assoc. 2021 Sep 21;10(18):e021686. doi: 10.1161/JAHA.121.021686. Epub 2021 Sep 6.
citation: Robinson CG, Samson PP, Moore KMS, Hugo GD, Knutson N, Mutic S, Goddu SM, Lang A, Cooper DH, Faddis M, Noheria A, Smith TW, Woodard PK, Gropler RJ, Hallahan DE, Rudy Y, Cuculich PS. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019 Jan 15;139(3):313-321. doi: 10.1161/CIRCULATIONAHA.118.038261.
citation: Loo BW Jr, Soltys SG, Wang L, Lo A, Fahimian BP, Iagaru A, Norton L, Shan X, Gardner E, Fogarty T, Maguire P, Al-Ahmad A, Zei P. Stereotactic ablative radiotherapy for the treatment of refractory cardiac ventricular arrhythmia. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):748-50. doi: 10.1161/CIRCEP.115.002765. No abstract available.
citation: Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773.