Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

Ventricular Tachycardia Clinical Trial

— RAVENTA  

Official title:

Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03867747
• Other study ID #: ZKS-121-09
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: October 20, 2024

Study information

• Verified date: March 2024
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

• 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 (according to CTCAE v5.0)

• Changes in patient-reported quality of life (recorded as EQ-5D-5L)

• Overall survival

• Safety profile

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 20, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with structural heart disease and implantable cardioverter defibrillator (ICD)

• 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:

• ICD electrode malfunction of ICD readings outside reference range

• 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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

Radiation:
• Cardiac Radiosurgery
Image-guided stereotactic body radiation therapy

Locations

Country	Name	City	State
Germany	University Medical Center Charite Berlin	Berlin
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	University Medical Center Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	University Medical Center Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	University Clinic Mannheim	Mannheim	Baden-Württemberg
Germany	Hospital of the Ludwig-Maximilians-University Munich	Munich	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports		30 days after radiosurgery
Secondary	Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports		12 months after radiosurgery
Secondary	Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks		At the time of inclusion and 12 months after radiosurgery
Secondary	Overall Survival		12 months after radiosurgery
Secondary	Quality of Life questionnaire (EQ-5D-5L)		At the time of inclusion and 12 months after radiosurgery