No registrations found.
ID
Source
Brief title
Health condition
Ventricular tachycardia
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The secondary outcome measure is a ≥50% reduction in daily dose class 1 and 3 anti-arrhythmic drugs at one year after treatment as compared to baseline
Background 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. 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.
Study objective
We hypothesize that stereotactic radiotherapy for the treatment of the cardiac arrhythmia ventricular tachycardia is effective and safe in therapy refractory patients
Study design
Outcomes will be assessed at 1, 3, 6 and 12 months after treatment
Intervention
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.
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7510 |
| CCMO | NL68191.018.19 |
| OMON | NL-OMON48498 |