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

January 6, 2025 updated by: Juergen Dunst, Prof., University Hospital Schleswig-Holstein

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • University Medical Center Charite Berlin
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • University Clinic Mannheim
    • Bayern
      • Munich, Bayern, Germany, 80336
        • Hospital of the Ludwig-Maximilians-University Munich
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • University Medical Center Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • University Medical Center Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Radiosurgery
25 Gy in a single fraction
Radiation: Cardiac Radiosurgery
Image-guided stereotactic body radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Time Frame: 30 days after radiosurgery
30 days after radiosurgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Time Frame: 12 months after radiosurgery
12 months after radiosurgery
Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks
Time Frame: At the time of inclusion and 12 months after radiosurgery
At the time of inclusion and 12 months after radiosurgery
Overall Survival
Time Frame: 12 months after radiosurgery
12 months after radiosurgery
Quality of Life questionnaire
Time Frame: At the time of inclusion and 12 months after radiosurgery
At the time of inclusion and 12 months after radiosurgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Juergen Dunst, Prof., University Hospital Schleswig-Holstein
  • Principal Investigator: Roland R Tilz, Prof., University Hospital Schleswig-Holstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2019

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKS-121-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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