SBRT for Ventricular Arrhythmia

NCT ID: NCT06411392

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-02-28

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.

Conditions

Ventricular Arrythmia

Study Design

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

Study Groups

Stereotactic Antiarrhythmic Radiotherapy

Stereotactic antiarrhythmic radiotherapy for refractory ventricular arrhythmia

Group Type: EXPERIMENTAL

Stereotactic Antiarrhythmic Radiotherapy

Intervention Type: RADIATION

Patients with ventricular tachycardia will undergo cardiac stereotactic antiarrhythmic radiotherapy with a single fraction of 25 Gy to the arrhythmia substrate, as determined by electrophysiological cardiac mapping.

Interventions

Stereotactic Antiarrhythmic Radiotherapy

Patients with ventricular tachycardia will undergo cardiac stereotactic antiarrhythmic radiotherapy with a single fraction of 25 Gy to the arrhythmia substrate, as determined by electrophysiological cardiac mapping.

Intervention Type: RADIATION

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

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

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Tanja Langsenlehner, MD

Role: CONTACT

tanja.langsenlehner@medunigraz.at

004331638587869

Facility Contacts

Tanja Langsenlehner, MD

Role: primary

tanja.langsenlehner@medunigraz.at

004331638587869

References

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.

Reference Type: BACKGROUND

PMID: 36072869 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34482706 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30586734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26082532 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29236642 (View on PubMed)

Other Identifiers

35-439 e 22/23

Identifier Type: -

Identifier Source: org_study_id