StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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 mechanism of action however remains unknown and should be elucidated.
The objective of this phase 2, single arm, monocenter, pre-post intervention study is to evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy and obtain insights in the mechanism of action by evaluating electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.
Eligibility criteria
Qualifiers
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, see below for full explanation)
At least 3 episodes of treated VT within the last 3 months
Disqualifiers
Pregnancy
History of radiation treatment in the thorax or upper abdominal region
Interstitial pulmonary disease
Trial design
Treatments tested in this trial
- Stereotactic Arrhythmia Radiotherapy
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Dutch Heart Foundation
Collaborator
Source ClinicalTrials.gov