We hypothesize that stereotactic radiotherapy for the treatment of the cardiac arrhythmia ventricular tachycardia is effective and safe in therapy refractory patients
ID
Bron
Verkorte titel
Aandoening
Ventricular tachycardia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main efficacy measure is a reduction in the number of ICD treated VT episodes by ≥50% at one year after treatment compared to the year before treatment.
Achtergrond van het onderzoek
Ventricular tachycardia (VT) is a malignant cardiac arrhythmia subjecting our patients to a high risk of sudden death, increased morbidity and reduced quality of life. Recent advances in cardiac electrophysiology and radiotherapy have enabled the use of non-invasive 3-dimensional cardiac mapping of these arrhythmias and the subsequent delivery of precise stereotactic radiotherapy to treat ventricular tachycardia. This study is designed to evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy in patients with ventricular tachycardia.
Doel van het onderzoek
We hypothesize that stereotactic radiotherapy for the treatment of the cardiac arrhythmia ventricular tachycardia is effective and safe in therapy refractory patients
Onderzoeksopzet
Outcomes will be assessed at 1, 3, 6 and 12 months after treatment
Onderzoeksproduct en/of interventie
The pro-arrhythmic cardiac region is identified by combining anatomical imaging with non-invasive body surface potential mapping during VT induction with non-invasive programmed stimulation. Radiotherapy simulation, planning and treatment is subsequently performed with the use of standard techniques. Patients are treated with a single radiotherapy fraction of 25 Gy at the determined pro-arrhythmic cardiac region.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1 Age >18 years
2 Implanted ICD
3 World Health Organization (WHO) / Eastern Cooperative Oncology Group (ECOG) performance status grade 0-3 in the
past 3 months (from fully active to capable of limited self-care, see below for full explanation)
4 At least 3 episodes of treated VT within the last 3 months
5 Recurrence of VT after
-Failed or intolerant to least one class 1 or class 3 anti-arrhythmic drug
AND
-At least one catheter ablation procedure OR considered to be unsuitable for a catheter ablation procedure (e.g. no
sufficient vascular access, considered unfit to undergo prolonged general anesthesia, comorbid conditions resulting
in unacceptable peri-procedural risks)
6 Able and willing to undergo all necessary evaluations, treatment and follow-up for the study and of follow-up thereafter
7 Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1 Pregnancy
2 History of radiation treatment in the thorax or upper abdominal region
3 Interstitial pulmonary disease
4 Renal insufficiency with a glomerular filtration rate <30ml/min
5 Refusal or inability to provide informed consent or to undergo all necessary evaluations, treatment and follow-up for the
study
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7510 |
| CCMO | NL68191.018.19 |
| OMON | NL-OMON48498 |