Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867747
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Universitätsmedizin Mannheim
Information provided by (Responsible Party):
Juergen Dunst, Prof., University of Schleswig-Holstein

Tracking Information
First Submitted Date  ICMJE March 5, 2019
First Posted Date  ICMJE March 8, 2019
Last Update Posted Date March 8, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports [ Time Frame: 30 days after radiosurgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports [ Time Frame: 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 ]
  • Overall Survival [ Time Frame: 12 months after radiosurgery ]
  • Quality of Life questionnaire (EQ-5D-5L) [ Time Frame: At the time of inclusion and 12 months after radiosurgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
Official Title  ICMJE Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)
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 (according to CTCAE v5.0)
  • Changes in patient-reported quality of life (recorded as EQ-5D-5L)
  • Overall survival
  • Safety profile
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Tachycardia
Intervention  ICMJE Radiation: Cardiac Radiosurgery
Image-guided stereotactic body radiation therapy
Study Arms  ICMJE Experimental: Cardiac Radiosurgery
25 Gy in a single fraction
Intervention: Radiation: Cardiac Radiosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juergen Dunst, Prof. +49431500 ext 26501 Juergen.Dunst@uksh.de
Contact: Oliver Blanck, Dr. +49431500 ext 26501 Oliver.Blanck@uksh.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03867747
Other Study ID Numbers  ICMJE ZKS-121-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juergen Dunst, Prof., University of Schleswig-Holstein
Study Sponsor  ICMJE University of Schleswig-Holstein
Collaborators  ICMJE Universitätsmedizin Mannheim
Investigators  ICMJE
Principal Investigator: Hendrik Bonnemeier, Prof. University of Schleswig-Holstein
Principal Investigator: Juergen Dunst, Prof. University of Schleswig-Holstein
PRS Account University of Schleswig-Holstein
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP