Stereotactic Arrhythmia Radiotherapy: Single radiation treatment of 25 Gy with external beam radiation therapy to the pro-arrhythmic region as determined by the cardiologist-electrophysiologist and radiation-oncologist combined
Study summary
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. Unfortunately, failure of treatment is common and VT recurrences remain an important concern. In these patients, stereotactic arrhythmia radiotherapy appears to be an effective and safe treatment. The mechanism of action however remains unknown and should be elucidated.
The objective of this phase 2, single arm, monocenter, pre-post intervention study is to evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy and obtain insights in the mechanism of action by evaluating electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥18 years
* Implanted ICD
* 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)
* At least 3 episodes of treated VT within the last 3 months
* 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)
* Able and willing to undergo all necessary evaluations, treatment and follow-up for the study and of follow-up thereafter
Exclusion Criteria:
* Pregnancy
* History of radiation treatment in the thorax or upper abdominal region
* Interstitial pulmonary disease
Primary outcome measure(s)
Reduction in the number of treated VT episodes — 18 months (excluding 3 months of blanking period) The main efficacy measure is a reduction in the number of treated VT episodes by ≥50% at the end of follow-up of 1 year (including a blanking period of 3 months). Net follow-up is 9 months compared to 9 months before treatment.
Rate of treatment related serious adverse events (SAEs) — 12 months The main safety measure is defined by a ≤20% rate of treatment related serious adverse events (SAEs), determined as the number of treatment related serious adverse events per number of treatment related adverse events.
Trial sites (1)
Facility
City
Region
Status
Amsterdam UMC location University of Amsterdam
Amsterdam
North Holland
Recruiting
More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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