cardiomyopathy life threatening arrhythmias cardiomyopathy life threatening arrhythmias
Conditions
Interventions
Patients are treated with a single radiotherapy fraction of 25 Gy targeting 
specifically the part of the identified VT substrate, which was not accessible 
by the current state of the art catheter ablation techniques (all maneuvers 
that are known to enhance lesion depth). Substrate identification is performed 
using the current state of the art techniques including real-time integration 
of electro-anatomical mapping data with cardiac imaging, including cardiac CT. 
This technique allows precise determination of the radiation volume by 
extracting mapping data together with the anatomical location on CT which can 
be used for the radiation planning
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age >=18 - Implanted ICD - Structural heart disease with myocardial scar - World Health Organization (WHO) / Eastern Cooperative Oncology Group (ECOG) performance status grade 0-3 in the past 3 months, or grade 4 if related to the ar-rhythmic presentation (from fully active to capable of limited self-care, see below for full explanation) - Presenting with at least one of the following * Within the past 3 months: electrical storm (defined as >=3 ICD shocks within 24h) * Within the past 3 months: 3 or more episodes of highly symptomatic sustained VT (either requiring ICD shocks, or leading to (pre)syncope) * Recurrent VT (high VT burden) leading to progressive heart failure * Symptomatic, incessant VT not detected by the device or reinitiating after ICD therapy * Progressive heart failure and indication for LVAD, in whom recurrent VT preclude LVAD implantation - Despite all of the following * Optimal medical treatment according to current guidelines * Failure of recommended antiarrhythmic drugs including failure of amiodarone * Failure of catheter ablation using the current state of the art catheter ablation techniques to modify the VT substrate - Able and willing to undergo all necessary evaluations, treatment and follow-up for the study and of follow-up thereafter - Informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Pregnancy - Interstitial pulmonary disease - Irreversible renal insufficiency with a glomerular filtration rate <30ml/min (not related to the high VT burden) - Life expectancy <12 months in the absence of VT - Refusal or inability to provide informed consent or to undergo all necessary evaluations, treatment and follow-up for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Number of patients in whom the (presumed) clinical VT(s) causing the presenting symptoms can be eliminated (equals: partial success in RFCA studies) for the study period of one year (after 6 weeks blanking). (2) Number of patients with the elimination of highly symptomatic VTs (e.g. pre-syncopal VT) or highly symptomatic ICD therapy (e.g. ICD shocks) for the study period of one year (after 6 weeks blanking). (3) Reduction of any ICD treated VT episodes by >=80% at one year after treatment compared to the year before treatment (including VTs during the 6 weeks blanking) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Time to elimination of the clinical VT(s) causing symptoms (2) Time to elimination of any sustained VT/ VT prompting ICD therapy (3) Elimination of the targeted arrhythmia substrate indicated by absence of inducible sustained VT at 6 months. (4) Modification of VT substrate indicated by voltage reduction and non-excitability during electroanatomical mapping at 6 months (5) number and dosage of class 1 and class 3 AAD at one year (6) *SUVmax on F18-FDG-PET/CT between baseline, 2 weeks and 6 months after treatment. | — |
Countries
Netherlands
Contacts
Public ContactR Rademaker
Leids Universitair Medisch Centrum
Outcome results
None listed