Mapping guided Stereotactic ablative Radiotherapy, Hybrid treatment for uncontrollable ventricular tachycardia

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(1) Number of patients in whom the (presumed) clinical VT(s) causing the<br /><br>presenting symptoms can be eliminated (equals: partial success in RFCA studies)<br /><br>for the study period of one year (after 6 weeks blanking).<br /><br>(2) Number of patients with the elimination of highly symptomatic VTs (e.g.<br /><br>pre-syncopal VT) or highly symptomatic ICD therapy (e.g. ICD shocks) for the<br /><br>study period of one year (after 6 weeks blanking).<br /><br>(3) Reduction of any ICD treated VT episodes by >=80% at one year after<br /><br>treatment compared to the year before treatment (including VTs during the 6<br /><br>weeks blanking)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) Time to elimination of the clinical VT(s) causing symptoms<br /><br>(2) Time to elimination of any sustained VT/ VT prompting ICD therapy<br /><br>(3) Elimination of the targeted arrhythmia substrate indicated by absence of<br /><br>inducible sustained VT at 6 months.<br /><br>(4) Modification of VT substrate indicated by voltage reduction and<br /><br>non-excitability during electroanatomical mapping at 6 months<br /><br>(5) number and dosage of class 1 and class 3 AAD at one year<br /><br>(6) *SUVmax on F18-FDG-PET/CT between baseline, 2 weeks and 6 months after<br /><br>treatment.</p><br>

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