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| Name | Class |
|---|---|
| Universitätsmedizin Mannheim | OTHER |
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Patients with refractory ventricular extrasystoles or tachycardia not eligible for catheter ablation will receive single fraction stereotactic body radiation therapy (cardiac radiosurgery) with 25 Gy.
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.
Primary endpoint: 30-day post-intervention safety defined as presence of both, radiosurgery delivery of the planned dose to the intended target area, and no possibly treatment related serious adverse events in the first 30 days after treatment.
Secondary endpoints: evaluated at 1 year
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Radiosurgery | Experimental | 25 Gy in a single fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Radiosurgery | Radiation | Image-guided stereotactic body radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports | 30 days after radiosurgery |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports | 12 months after radiosurgery | |
| Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks | At the time of inclusion and 12 months after radiosurgery |
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Inclusion Criteria:
Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
Age > 18 years
either
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:
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| Name | Affiliation | Role |
|---|---|---|
| Roland R Tilz, Prof. | University Hospital Schleswig-Holstein | Principal Investigator |
| Juergen Dunst, Prof. | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany | ||
| Hospital of the Ludwig-Maximilians-University Munich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32306083 | Background | 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. | |
| 33508373 |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Overall Survival | 12 months after radiosurgery |
| Quality of Life questionnaire | At the time of inclusion and 12 months after radiosurgery |
| Munich |
| Bavaria |
| 80336 |
| Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| University Medical Center Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| University Medical Center Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23562 | Germany |
| University Medical Center Charite Berlin | Berlin | 10117 | Germany |
| Background |
| 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. |
| 34380072 | Background | 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. |
| 35716847 | Background | 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. |
| 36655216 | Background | 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. |
| 39242029 | Background | 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. |
| 37285038 | Result | 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. |
| 37698592 | Result | 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. |
| 38193546 | Result | 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |