SBRT for Ventricular Arrhythmia

NCT06411392 | Recruiting

• 1 other identifier: 35-439 e 22/23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

stereotactic radiotherapy

Outcome Measures

Primary Outcomes (2)

• Safety of treatment

  Demonstration of acute (≤ 30 days) safety of non-invasive stereotactic antiarrhythmic radiotherapy for ventricular arrhythmia (STAR). The primary safety endpoint is defined as ≤ 20% rate of severe adverse events according to CTCAE v5.0 criteria

  30 days

• Efficacy of treatment

  The efficacy endpoint is defined by the number of patients experiencing a reduction in ventricular tachycardia episodes, compared to the six-month period prior to SBRT treatment and the six-month period post- SBRT.

  6 months

Secondary Outcomes (3)

• Evaluation of changes in the left ventricular ejection fraction

  12 months

• Evaluation of mortality

  12 months

• Assessment of late side effects

  12 months

Study Arms (1)

Stereotactic Antiarrhythmic Radiotherapy

EXPERIMENTAL

Stereotactic antiarrhythmic radiotherapy for refractory ventricular arrhythmia

Radiation: Stereotactic Antiarrhythmic Radiotherapy

Interventions

Stereotactic Antiarrhythmic Radiotherapy 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.

Stereotactic Antiarrhythmic Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

Related Publications (5)

• 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.

  PMID: 36072869 BACKGROUND

• 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.

  PMID: 34482706 BACKGROUND

• 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.

  PMID: 30586734 BACKGROUND

• 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.

  PMID: 26082532 BACKGROUND

• 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.

  PMID: 29236642 RESULT

Central Study Contacts

Tanja Langsenlehner, MD

CONTACT

004331638587869; tanja.langsenlehner@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)