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Trial record 12 of 136 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

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

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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

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.


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Radiation: Cardiac Radiosurgery Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports [ Time Frame: 30 days after radiosurgery ]

Secondary Outcome Measures :
  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 (EQ-5D-5L) [ Time Frame: At the time of inclusion and 12 months after radiosurgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867747


Contacts
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Contact: Juergen Dunst, Prof. +49431500 ext 26501 Juergen.Dunst@uksh.de
Contact: Oliver Blanck, Dr. +49431500 ext 26501 Oliver.Blanck@uksh.de

Locations
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Germany
University Clinic Mannheim Not yet recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Contact: Judit Boda-Heggemann, PD Dr.    +49621383 ext 6020    judit.boda-heggemann@umm.de   
Contact: Daniel Bürgy, Dr.    +49621383 ext 6020    daniel.buergy@medma.uni-heidelberg.de   
Principal Investigator: Judit Boda-Heggemann, PD Dr.         
Sub-Investigator: Daniel Bürgy, Dr.         
University Medical Center Schleswig-Holstein Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Juergen Dunst, Prof.    +49431500 ext 26501    Juergen.Dunst@uksh.de   
Contact: Oliver Blanck, Dr.    +49431500 ext 26501    Oliver.Blanck@uksh.de   
Principal Investigator: Juergen Dunst, Prof.         
Sub-Investigator: David Krug, Dr.         
Sponsors and Collaborators
University of Schleswig-Holstein
Universitätsmedizin Mannheim
Investigators
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Principal Investigator: Hendrik Bonnemeier, Prof. University of Schleswig-Holstein
Principal Investigator: Juergen Dunst, Prof. University of Schleswig-Holstein

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Responsible Party: Juergen Dunst, Prof., Prof. Dr. med. Juergen Dunst, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03867747     History of Changes
Other Study ID Numbers: ZKS-121-09
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juergen Dunst, Prof., University of Schleswig-Holstein:
Ventricular Tachycardia
Stereotactic Body Radiation Therapy
Radiosurgery
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Cardiac Complexes, Premature
Ventricular Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes