Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
NCT ID: NCT03867747
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-12-02
2024-10-20
Brief Summary
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Investigators initiated this study to demonstrate that in at least 70% of the patients the planned cardiac radiosurgery may be performed without any interruption or treatment related interventional events within the first 30 days after treatment.
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Detailed Description
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Secondary endpoints: evaluated at 1 year
* Changes in ventricular tachycardia episodes and ICD shocks
* Changes in antiarrhythmic medication due to treatment effects
* Occurrence of possibly treatment related adverse events in the first year after treatment
* Changes in patient-reported quality of life
* Overall survival
* Safety profile
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cardiac Radiosurgery
25 Gy in a single fraction
Cardiac Radiosurgery
Image-guided stereotactic body radiation therapy
Interventions
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Cardiac Radiosurgery
Image-guided stereotactic body radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* either
1. Recurring symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). At least 3 episodes within the 3 months prior to inclusion or
2. induction of symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). Induction triggered by ICD or during electrophysiology studies (EPS) or both, a) and b)
* Refractory to antiarrhythmic combination therapy
* Beside the cardiac conditions: No competing illness that would additionally limit the life expectancy to less than 6 months
* No prior radiation therapy in the thorax area
* No pregnancy and no active breastfeeding
* Ability to consent and consent to study participation
Exclusion Criteria
* Lack of evidence of a myocardial scar (Computer tomography or magnetic resonance tomography for MRI-capable ICD aggregates or electrophysiological measurement)
* No possible induction of symptomatic monomorphic ventricular tachycardia non-persistent or persistent with delivery of ICD therapies such as antitachycardic pacing or shock
* Contraindication to radiosurgery (e.g. precise target volume definition not possible due to image artifacts created from a left ventricular assist device (LVAD))
* Inability to consent or missing or withdrawn consent
18 Years
ALL
No
Sponsors
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Universitätsmedizin Mannheim
OTHER
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Juergen Dunst, Prof.
Prof. Dr. med. Juergen Dunst
Principal Investigators
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Roland R Tilz, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Juergen Dunst, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Locations
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University Clinic Mannheim
Mannheim, Baden-Wurttemberg, Germany
Hospital of the Ludwig-Maximilians-University Munich
Munich, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
University Medical Center Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
University Medical Center Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
University Medical Center Charite Berlin
Berlin, , Germany
Countries
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References
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Blanck O, Buergy D, Vens M, Eidinger L, Zaman A, Krug D, Rudic B, Boda-Heggemann J, Giordano FA, Boldt LH, Mehrhof F, Budach V, Schweikard A, Olbrich D, Konig IR, Siebert FA, Vonthein R, Dunst J, Bonnemeier H. Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA). Clin Res Cardiol. 2020 Nov;109(11):1319-1332. doi: 10.1007/s00392-020-01650-9. Epub 2020 Apr 18.
Boda-Heggemann J, Blanck O, Mehrhof F, Ernst F, Buergy D, Fleckenstein J, Tulumen E, Krug D, Siebert FA, Zaman A, Kluge AK, Parwani AS, Andratschke N, Mayinger MC, Ehrbar S, Saguner AM, Celik E, Baus WW, Stauber A, Vogel L, Schweikard A, Budach V, Dunst J, Boldt LH, Bonnemeier H, Rudic B. Interdisciplinary Clinical Target Volume Generation for Cardiac Radioablation: Multicenter Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):745-756. doi: 10.1016/j.ijrobp.2021.01.028. Epub 2021 Jan 27.
Krug D, Blanck O, Andratschke N, Guckenberger M, Jumeau R, Mehrhof F, Boda-Heggemann J, Seidensaal K, Dunst J, Pruvot E, Scholz E, Saguner AM, Rudic B, Boldt LH, Bonnemeier H. Recommendations regarding cardiac stereotactic body radiotherapy for treatment refractory ventricular tachycardia. Heart Rhythm. 2021 Dec;18(12):2137-2145. doi: 10.1016/j.hrthm.2021.08.004. Epub 2021 Aug 8.
Kluge A, Ehrbar S, Grehn M, Fleckenstein J, Baus WW, Siebert FA, Schweikard A, Andratschke N, Mayinger MC, Boda-Heggemann J, Buergy D, Celik E, Krug D, Kovacs B, Saguner AM, Rudic B, Bergengruen P, Boldt LH, Stauber A, Zaman A, Bonnemeier H, Dunst J, Budach V, Blanck O, Mehrhof F. Treatment Planning for Cardiac Radioablation: Multicenter Multiplatform Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. Int J Radiat Oncol Biol Phys. 2022 Jun 15;114(2):360-372. doi: 10.1016/j.ijrobp.2022.06.056.
Mayinger M, Boda-Heggemann J, Mehrhof F, Krug D, Hohmann S, Xie J, Ehrbar S, Kovacs B, Merten R, Grehn M, Zaman A, Fleckenstein J, Kaestner L, Buergy D, Rudic B, Kluge A, Boldt LH, Dunst J, Bonnemeier H, Saguner AM, Andratschke N, Blanck O, Schweikard A. Quality assurance process within the RAdiosurgery for VENtricular TAchycardia (RAVENTA) trial for the fusion of electroanatomical mapping and radiotherapy planning imaging data in cardiac radioablation. Phys Imaging Radiat Oncol. 2022 Dec 26;25:100406. doi: 10.1016/j.phro.2022.12.003. eCollection 2023 Jan.
Hohmann S, Xie J, Eckl M, Grehn M, Karfoul N, Janorschke C, Merten R, Rudic B, Buergy D, Lyan E, Krug D, Mehrhof F, Boldt LH, Corradini S, Fanslau H, Kaestner L, Zaman A, Giordano FA, Duncker D, Dunst J, Tilz RR, Schweikard A, Blanck O, Boda-Heggemann J. Semi-automated reproducible target transfer for cardiac radioablation - A multi-center cross-validation study within the RAVENTA trial. Radiother Oncol. 2024 Nov;200:110499. doi: 10.1016/j.radonc.2024.110499. Epub 2024 Sep 4.
Krug D, Zaman A, Eidinger L, Grehn M, Boda-Heggemann J, Rudic B, Mehrhof F, Boldt LH, Hohmann S, Merten R, Buergy D, Fleckenstein J, Kluge A, Rogge A, Both M, Rades D, Tilz RR, Olbrich D, Konig IR, Siebert FA, Schweikard A, Vonthein R, Bonnemeier H, Dunst J, Blanck O. Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial. Strahlenther Onkol. 2023 Jul;199(7):621-630. doi: 10.1007/s00066-023-02091-9. Epub 2023 Jun 7.
Kaestner L, Boda-Heggemann J, Fanslau H, Xie J, Schweikard A, Giordano FA, Blanck O, Rudic B. Electroanatomical mapping after cardiac radioablation for treatment of incessant electrical storm: a case report from the RAVENTA trial. Strahlenther Onkol. 2023 Nov;199(11):1018-1024. doi: 10.1007/s00066-023-02136-z. Epub 2023 Sep 12.
Mehrhof F, Huttemeister J, Tanacli R, Bock M, Bogner M, Schoenrath F, Falk V, Zips D, Hindricks G, Gerds-Li JH, Hohendanner F. Cardiac radiotherapy transiently alters left ventricular electrical properties and induces cardiomyocyte-specific ventricular substrate changes in heart failure. Europace. 2023 Dec 28;26(1):euae005. doi: 10.1093/europace/euae005.
Other Identifiers
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ZKS-121-09
Identifier Type: -
Identifier Source: org_study_id
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