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Completed

NCT Number: NCT03867747

Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Mannheim, Mannheim, Baden-Wurttemberg, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Treatment and study plan

Cardiac Radiosurgery

Radiation

Image-guided stereotactic body radiation therapy

Primary outcomes

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

    Time frame: 30 days after radiosurgery

Secondary outcomes

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

    Time frame: 12 months after radiosurgery

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

    Time frame: At the time of inclusion and 12 months after radiosurgery

  3. Overall Survival

    Time frame: 12 months after radiosurgery

  4. Quality of Life questionnaire

    Time frame: At the time of inclusion and 12 months after radiosurgery

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • Universitätsmedizin Mannheim

Registry information

Official study title

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

Acronym: RAVENTA

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 8, 2019
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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