Clinical trial NCT03867747: Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
Official title: Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Ventricular Tachycardia
Stereotactic Body Radiation Therapy
Radiosurgery
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Universitätsmedizin Mannheim
First posted: 2019-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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
* Changes in patient-reported quality of life
* Overall survival
* Safety profile

Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
timeFrame: 30 days after radiosurgery
Secondary outcomes:
measure: Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
timeFrame: 12 months after radiosurgery
measure: Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks
timeFrame: At the time of inclusion and 12 months after radiosurgery
measure: Overall Survival
timeFrame: 12 months after radiosurgery
measure: Quality of Life questionnaire
timeFrame: At the time of inclusion and 12 months after radiosurgery
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Clinic Mannheim
state: Baden-Württemberg
city: Munich
country: Germany
facility: Hospital of the Ludwig-Maximilians-University Munich
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: University Medical Center Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: University Medical Center Charite Berlin
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Roland R Tilz, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Schleswig-Holstein
name: Juergen Dunst, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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