- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06411392
SBRT for Ventricular Arrhythmia
May 8, 2024 updated by: Medical University of Graz
Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tanja Langsenlehner, MD
- Phone Number: 004331638587869
- Email: tanja.langsenlehner@medunigraz.at
Study Locations
-
-
-
Graz, Austria, 8036
- Recruiting
- Medical University of Graz
-
Principal Investigator:
- Tanja Langsenlehner, MD
-
Contact:
- Tanja Langsenlehner, MD
- Phone Number: 004331638587869
- Email: tanja.langsenlehner@medunigraz.at
-
Principal Investigator:
- Daniel Scherr, MD
-
Sub-Investigator:
- Lukas Seiß
-
Sub-Investigator:
- Ursula Rohrer, MD
-
Sub-Investigator:
- Peter Winkler, PhD
-
Sub-Investigator:
- Martin Manninger-Wünscher, MD
-
Sub-Investigator:
- Thomas Brunner, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stereotactic Antiarrhythmic Radiotherapy
Stereotactic antiarrhythmic radiotherapy for refractory ventricular arrhythmia
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of treatment
Time Frame: 30 days
|
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
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of changes in the left ventricular ejection fraction
Time Frame: 12 months
|
Evaluation of changes in the left ventricular ejection fraction analyzed with echocardiography
|
12 months
|
Evaluation of mortality
Time Frame: 12 months
|
Analysis of cardiac mortality during post-treatment follow-up
|
12 months
|
Assessment of late side effects
Time Frame: 12 months
|
Assessment of radiation-induced cardiac late side effects using late iodine computed tomography
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: J Am Heart Assoc. 2023 May 16;12(10):e027687.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
May 8, 2024
First Submitted That Met QC Criteria
May 8, 2024
First Posted (Actual)
May 13, 2024
Study Record Updates
Last Update Posted (Actual)
May 13, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35-439 e 22/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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