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

Primary Purpose

Ventricular Tachycardia

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cardiac Radiosurgery
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ventricular Tachycardia, Stereotactic Body Radiation Therapy, Radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Inability to consent or missing or withdrawn consent

Sites / Locations

  • University Clinic MannheimRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • Universitätsklinikum BonnRecruiting
  • University Medical Center Schleswig-HolsteinRecruiting
  • University Medical Center Charite BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Radiosurgery

Arm Description

25 Gy in a single fraction

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks
Overall Survival
Quality of Life questionnaire (EQ-5D-5L)

Full Information

First Posted
March 5, 2019
Last Updated
March 31, 2022
Sponsor
University Hospital Schleswig-Holstein
Collaborators
Universitätsmedizin Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT03867747
Brief Title
Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
Acronym
RAVENTA
Official Title
Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
Universitätsmedizin Mannheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular Tachycardia, Stereotactic Body Radiation Therapy, Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Radiosurgery
Arm Type
Experimental
Arm Description
25 Gy in a single fraction
Intervention Type
Radiation
Intervention Name(s)
Cardiac Radiosurgery
Intervention Description
Image-guided stereotactic body radiation therapy
Primary Outcome Measure Information:
Title
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Time Frame
30 days after radiosurgery
Secondary Outcome Measure Information:
Title
Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Time Frame
12 months after radiosurgery
Title
Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks
Time Frame
At the time of inclusion and 12 months after radiosurgery
Title
Overall Survival
Time Frame
12 months after radiosurgery
Title
Quality of Life questionnaire (EQ-5D-5L)
Time Frame
At the time of inclusion and 12 months after radiosurgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Dunst, Prof.
Phone
+49431500
Ext
26501
Email
Juergen.Dunst@uksh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Blanck, Dr.
Phone
+49431500
Ext
26501
Email
Oliver.Blanck@uksh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Bonnemeier, Prof.
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, Prof.
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Mannheim
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judit Boda-Heggemann, MD
Phone
+49621383
Ext
6020
Email
judit.boda-heggemann@umm.de
First Name & Middle Initial & Last Name & Degree
Daniel Bürgy, MD
Phone
+49621383
Ext
6020
Email
daniel.buergy@medma.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Judit Boda-Heggemann, MD
First Name & Middle Initial & Last Name & Degree
Daniel Bürgy, MD
First Name & Middle Initial & Last Name & Degree
Boris Rudic, MD
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Hohmann, MD
Phone
+49511532
Ext
3817
Email
Hohmann.Stephan@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Roland Merten, MD
Phone
+49511532
Ext
2574
Email
strahlentherapie@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Stephan Hohmann, MD
First Name & Middle Initial & Last Name & Degree
Roland Merten, MD
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Giordano, MD
Phone
+49228287
Ext
10354
Email
Frank.Giordano@ukbonn.de
First Name & Middle Initial & Last Name & Degree
Thomas Beiert, MD
Phone
+49228287
Ext
15507
Email
Thomas.Beiert@ukbonn.de
First Name & Middle Initial & Last Name & Degree
Frank Giordano, MD
First Name & Middle Initial & Last Name & Degree
Thomas Beiert, MD
Facility Name
University Medical Center Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, Prof.
Phone
+49431500
Ext
26501
Email
Juergen.Dunst@uksh.de
First Name & Middle Initial & Last Name & Degree
Oliver Blanck, Dr.
Phone
+49431500
Ext
26501
Email
Oliver.Blanck@uksh.de
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, Prof.
First Name & Middle Initial & Last Name & Degree
David Krug, Dr.
Facility Name
University Medical Center Charite Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Mehrhof, MD
Phone
+4930455
Ext
57088
Email
felix.mehrhof@charite.de
First Name & Middle Initial & Last Name & Degree
Leif-Hendrik Boldt, MD
Phone
+4930455
Ext
653722
Email
leif-hendrik.boldt@charite.de
First Name & Middle Initial & Last Name & Degree
Felix Mehrhof, MD
First Name & Middle Initial & Last Name & Degree
Leif-Hendrik Boldt, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32306083
Citation
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.
Results Reference
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PubMed Identifier
33508373
Citation
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.
Results Reference
background
PubMed Identifier
33160007
Citation
Lydiard PGDip S, Blanck O, Hugo G, O'Brien R, Keall P. A Review of Cardiac Radioablation (CR) for Arrhythmias: Procedures, Technology, and Future Opportunities. Int J Radiat Oncol Biol Phys. 2021 Mar 1;109(3):783-800. doi: 10.1016/j.ijrobp.2020.10.036. Epub 2020 Nov 5.
Results Reference
background
PubMed Identifier
34380072
Citation
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.
Results Reference
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Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

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