Ventricular tachycardias
Conditions
Interventions
Stereotactic radiotherapy
Sponsors
Departments of Cardiology and Radiotherapy, Leiden University Medical Center
Eligibility
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 arrhythmic 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. | — |
Contacts
Public ContactKatja Zeppenfeld
LUMC
Outcome results
None listed