ELectroanatomic substrate-guided STereotactic Ablative Radiotherapy for refractory Ventricular Tachycardia

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 23

Inclusion Criteria

• Structural heart disease (ischemic and non-ischemic cardiomyopathy) with
myocardial scar and
previous ICD implantation.
• 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).

• Recurrent VT:
• Despite > 1 prior catheter ablation (last in expert center) with all
meaningful mapping/ablation
approaches performed (endo/epicardial, LV/RV), a detailed
electroanatomical map of substrate
and precise image integration available.
OR
• In a patient that is ineligible to undergo invasive catheter ablation
(e.g., LV thrombus, double
mechanical valves, no vascular access) but with detailed (noninvasive)
electroanatomical
information and precise image integration available.

• Recurrent VT should be:
• Sustained monomorphic VT, compatible with the arrhythmogenic substrate.
• >= 3 VT episodes (syncope, sustained VT, antitachypacing treated or ICD
shock) in previous 6
months OR electrical storm (>= 3 VTs in 24 h) OR symptomatic incessant VT.
• Recorded on 12-lead and compatible with the arrhythmogenic substrate.

• Antiarrhythmic drugs:
• Optimal medical treatment according to current ESC guidelines.
• Failed, intolerance or contraindication to >= 1 antiarrhythmic drugs
(amiodarone, sotalol, mexiletine,
procainamide).

• Patient must be able to understand and be willing to sign an Institutional
Review Board (IRB)-
approved written informed consent.

Exclusion Criteria

A patient that meets any of the following criteria will be excluded from
participation:
• Age < 18 years.
• Advanced heart failure New York Heart Association (NYHA) class IV or
requiring inotropic treatment or mechanical assistance.
• Reversible cause underlying the arrhythmia.
• Interstitial pulmonary disease.
• Acute coronary syndrome, percutaneous coronary intervention or cardiac
surgery in last 3 months.
• Life expectancy in absence of VT <12 months.
• Polymorphic VT, torsades de pointes or VF.
• Pregnancy or breastfeeding.
• Overlapping prior radiotherapy to the thoracic region resulting in a
cumulative dose that is deemed unsafe by the treating physician.
• Advanced myocardial scar substrate that would require stereotactic delivery
to a target volume deemed unsafe by the treating physician.
• Refusal or inability to provide informed consent or to undergo all necessary
evaluations, treatment and follow-up for the study.
• Renal insufficiency with a glomerular filtration rate <30ml/min.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of patients with >=80% reduction of VT burden, i.e., any ICD-treated or<br /><br>highly-symptomatic VT episodes, at one year after STAR compared to the year<br /><br>before (including VTs during the 8 week-blanking period).<br /><br><br /><br>Efficacy parameters will be assessed by comparing the 12 months prior to STAR<br /><br>with the 12 months after treatment. All arrhythmic episodes occurring during<br /><br>the blanking period will be collected.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Baseline study parameters such as age, gender, underlying cardiac disease, LV<br /><br>ejection fraction, scar anatomy (3DMRI, electroanatomical map), death,<br /><br>(in)appropriate ICD therapy, antitachypacing, use of antiarrhythmic drugs,<br /><br>target dose-volume parameters, healthy tissue dose-volume parameters, toxicity,<br /><br>quality of life, hospitalisation, ECG-imaging (activation and repolarization<br /><br>times, fragmentation, activation/propagation maps) will be collected and<br /><br>investigated.</p><br>

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