To evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main efficacy measure is a reduction in the number of treated VT episodes
by *50% at one year after treatment compared to the year before treatment. The
main safety measure for adverse cardiac effects is a >25% relative decrease in
left ventricular ejection fraction measured by echocardiography at one year
after treatment as compared to baseline and for adverse pulmonary effects a
>25% relative decrease in forced expiratory volume in 1 second (FEV1) or
diffusing capacity (DLCO) measured by pulmonary functions tests at one year
after treatment as compared to baseline.
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.
Study objective
To evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy in
patients with therapy refractory ventricular tachycardia.
Study design
This will be a pre-post intervention study, single arm, phase 2, using
non-invasive 3-dimensional cardiac mapping of ventricular tachycardia and the
subsequent delivery of precise stereotactic radiotherapy to treat ventricular
tachycardia designed to define efficacy and safety of this treatment in our
patient population.
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.
Study burden and risks
Our study population will consist of critically ill and mostly older patients
with a high disease burden, both somatically and psychologically. With
non-invasive stereotactic radio-ablation therapy spectacular results have been
reported with a decrease of over 90% in the occurrence of VT in therapy
refractory patients. The impact of these results on disease burden and quality
of life can be enormous. The promising results are accompanied by a
simultaneously promising safety profile at 6 months and one year follow-up
respectively. Late adverse cardiac effects after radiotherapy in the context of
cancer treatment have been described. These effects will often be treatable if
occurring. Furthermore, patients who will be eligible for this study have a
significant decreased long-term survival.
The work-up for stereotactic radio-ablation therapy is extensive. If no recent
image studies are available they will be repeated. Also, blood tests, an
echocardiography and lung function tests will be performed. An
electrophysiology study will be performed using body surface potential mapping
to determine the starting point of the arrhythmia VT.
The treatment itself takes 15-20 minutes and is completely non-invasive and
painless. After treatment with radiotherapy, patients will be observed for 24
hours at the cardiology department. Because this study involves a relative new
treatment, patients will be closely monitored. Patients will have two
additional outpatient clinic visits in comparison to patients undergoing
conventional catheter ablation therapy. Furthermore, follow-up includes more
blood tests, two times an echocardiography and two lung function tests to
assess for potential adverse events.
We think these potential benefits outweigh the possible adverse effects in this
critical-ill patient population with no other therapeutic options. Furthermore,
we think they justify the additional outpatient clinic visits and additional
examinations.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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)
- At least 3 episodes of treated VT within the last 3 months
- Recurrence of VT after
o Failed or intolerance to at least one class 1 or class 3
anti-arrhythmic drug
AND
o 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
- Informed consent
Exclusion criteria
- Pregnancy
- History of radiation treatment in the thorax or upper abdominal region
- Interstitial pulmonary disease
- Renal insufficiency with a glomerular filtration rate <30ml/min
- Refusal or inability to provide informed consent or to undergo all necessary
evaluations,
treatment and follow-up for the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68191.018.19 |
| OMON | NL-OMON22142 |