Stereotactic Arrhythmia Radiotherapy in the Netherlands no. 1

Phase 2

Completed

Conditions: heart rhythm disorder
ventricular arrhythmia
Ventricular tachycardia
10007521

Registration Number: NL-OMON48498

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main efficacy measure is a reduction in the number of treated VT episodes<br /><br>by *50% at one year after treatment compared to the year before treatment. The<br /><br>main safety measure for adverse cardiac effects is a >25% relative decrease in<br /><br>left ventricular ejection fraction measured by echocardiography at one year<br /><br>after treatment as compared to baseline and for adverse pulmonary effects a<br /><br>>25% relative decrease in forced expiratory volume in 1 second (FEV1) or<br /><br>diffusing capacity (DLCO) measured by pulmonary functions tests at one year<br /><br>after treatment as compared to baseline. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measure is a *50% reduction in daily dose class 1 and 3<br /><br>anti-arrhythmic drugs at one year after treatment as compared to baseline.</p><br>