heart rhythm disorder ventricular arrhythmia Ventricular tachycardia
Conditions
Interventions
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 inf
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Pregnancy - History of radiation treatment in the thorax or upper abdominal region - Interstitial pulmonary disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed