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Ventricular TachycardiaRAVENTANCT03867747

Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

A study testing Cardiac Radiosurgery in people with Ventricular Tachycardia, run by University Hospital Schleswig-Holstein at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Tachycardia
What is being tested?
Cardiac Radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
6 sitesGermany
Study dates
2 Dec 2019to 20 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
  • Age > 18 years
  • either
  • 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
  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • University Medical Center Charite Berlin

    Berlin, 10117

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • University Medical Center Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • University Medical Center Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23562

  • University Clinic Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Hospital of the Ludwig-Maximilians-University Munich

    Munich, Bavaria, 80336

Other trials in Germany

About this study

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

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.

Read the 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
Being tested
Cardiac Radiosurgery
Keywords
Ventricular Tachycardia, Stereotactic Body Radiation Therapy, Radiosurgery
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac RadiosurgeryRadiation

    Image-guided stereotactic body radiation therapy

Study groups in NCT03867747
Study groupRoleWhat they receive
Cardiac RadiosurgeryExperimental25 Gy in a single fraction
Receives: Radiation: Cardiac Radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports

    Measured: 30 days after radiosurgery

Secondary outcomes (4)

  1. Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports

    Measured: 12 months after radiosurgery

  2. Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks

    Measured: At the time of inclusion and 12 months after radiosurgery

  3. Overall Survival

    Measured: 12 months after radiosurgery

  4. Quality of Life questionnaire

    Measured: At the time of inclusion and 12 months after radiosurgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2019
  2. Study start2 Dec 2019
  3. Primary completion20 Nov 2023
  4. Study completion20 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867747
Sponsor's protocol ID
ZKS-121-09
Acronym
RAVENTA
Status last verified
Jan 2025
First submitted
5 Mar 2019
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32306083

  • 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.

    PubMed 33508373

  • 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.

    PubMed 34380072

  • 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.

    PubMed 35716847

  • 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.

    PubMed 36655216

  • 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.

    PubMed 39242029

  • 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.

    PubMed 37285038

  • 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.

    PubMed 37698592

  • 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.

    PubMed 38193546

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Radiosurgery in people with Ventricular Tachycardia, run by University Hospital Schleswig-Holstein at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports (time frame: 30 days after radiosurgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867747, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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