Stereotactic Arrhythmia Radiotherapy in the Netherlands no. 2

Phase 2

Recruiting

Conditions: heart rhythm disorder
ventricular arrhythmia
Ventricular tachycardia
10007521

Registration Number: NL-OMON51339

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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

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 is defined by a <=20% rate of treatment related serious<br /><br>adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy measures include reduction of VT episodes by >=70%, changes<br /><br>in daily dose of anti-arrhythmic drugs and changes in quality of life comparing<br /><br>baseline to end of follow-up. Secondary safety measures include changes in<br /><br>cardiac and pulmonary function.</p><br>