To confirm our STARNL-1 pilot efficacy and safety data in a larger cohort and obtain insights in the mechanism of action by evaluating electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory…
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 is defined by a <=20% rate of treatment related serious
adverse events.
Secondary outcome
Secondary efficacy measures include reduction of VT episodes by >=70%, changes
in daily dose of anti-arrhythmic drugs and changes in quality of life comparing
baseline to end of follow-up. Secondary safety measures include changes in
cardiac and pulmonary function.
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. 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
working mechanism however remains unknown and should be elucidated.
Study objective
To confirm our STARNL-1 pilot efficacy and safety data in a larger cohort and
obtain insights in the mechanism of action by evaluating electro-anatomical
alterations of stereotactic arrhythmia radiotherapy in patients with therapy
refractory ventricular tachycardia.
Study design
Pre-post intervention study, single arm, phase 2.
Intervention
Patients are treated with a single radiotherapy fraction of 25 Gy at the
determined pro-arrhythmic cardiac region. The pro-arrhythmic cardiac region is
determined by combining electro-anatomical information. Treatment is
subsequently performed with the use of standard radiotherapy techniques as
previously described.
Study burden and risks
At baseline, patients will undergo extensive evaluations to 1. determine the
pro-arrhythmic region for treatment and 2. to gain baseline functional and
electro-anatomical information. After radiotherapy simulation and planning, the
radiotherapy treatment will be scheduled as a hospital admission. ICD
interrogations, quality of life questionnaires, laboratory tests and assessment
of adverse events will be performed at 1 week and 1, 3, 6, 9 and 12 months
after treatment. Patients will undergo repeated electro-anatomical imaging and
pulmonary function tests at 3 and 12 months.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
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 intolerant to 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
Exclusion criteria
- Pregnancy
- History of radiation treatment in the thorax or upper abdominal region
- Interstitial pulmonary disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt. |
| CCMO | NL80617.018.22 |