StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 1

Recruiting

Conditions: Ventricular tachycardia

Registration Number: NL-OMON22142

Lead Sponsor: Amsterdam University Medical Centers

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

1Age >18 years

2Implanted ICD

3World 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

1Pregnancy

2History of radiation treatment in the thorax or upper abdominal region

3Interstitial pulmonary disease

4Renal insufficiency with a glomerular filtration rate <30ml/min

5Refusal 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
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 Measures

Name	Time	Method
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