Ventricular Tachycardia (VT)
Conditions
Keywords
ventricular tachycardia, STAR, Stereotactic radiotherapy
Brief summary
Steoreotactic therapy radioablation has become a standard of care option for patients with therapy-refractory ventricular tachycardia, yet long-term outcome is lacking. The objective of this study is to evaluate the long-term outcomes, both efficacy and safety, after STAR in patients with therapy-refractory ventricular tachycardia.
Interventions
PROCEDUREstereotactic radiotherapy ablation
Single dose of 25 Gy up to 32.5 Gy on the myocardium in patients with therapy-refractory ventricular tachycardia
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for STAR for therapy-refractory VT based on a multidisciplinary discussion * Ability to give a written informed consent and willingness to return for follow-up
Exclusion criteria
* Contra-indications for STAR, including pregnancy or breastfeeding, previous radiotherapy with cardiac involvement, life-expectancy \< 6 months in the absence of VT * Any condition that is deemed a contraindication in the judgment of the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VT burden | 48 months | Change in VT burden, measured as the frequency of appropriate ICD interventions or documented VT episodes over a 48-month follow-up period. The ICD interrogations are part of standard of care and the majority of patients are included in remote monitoring which automatically sends new VT episodes to the telemonitoring team. The efficacy of STAR will be assessed by analysing both the total VT burden, but also time to first VT event (with and without a 6 week blanking period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months | The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state over a 48-month follow-up period. |
| All-cause mortality | 48 months | Survival will be tracked during the 48-month follow-up period. In case of mortality, the cause of death will be registered. |
| Radiotherapy toxicity | 48 months | The tolerable acute toxicity rate is defined as a 30-days follow-up without treatment-related grade ≥ 3 adverse events. Late toxicity is defined as toxicity occurring after at least 30 days after the radiation treatment. Toxicity will be assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). |
| Left ventricular function | Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months | Left ventricular function on transthoracic echocardiogram (TTE) by measuring left ventricular ejection fraction. |
| Evolution of valve disease | Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months | Change of pre-existing or new valve stenosis and insufficiency expressed as grade 0 / I / II / III / IV on transthoracic echocardiogram (TTE). |
| Change of coronary artery disease | Baseline, 2 years and 4 years | Presence and extent of coronary artery disease on CT coronary angiogram at 2 and 4 years follow-up using the calcium score and CAD-RADs stage. |
Countries
Belgium
Contacts
CONTACTBert Vandenberk, MD PhD
CONTACTPatrick Berkovic, MD PhD
Outcome results
None listed