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StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2

RecruitingPhase 2Ages 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT05439031 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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, see below for full explanation) * At least 3 episodes of treated VT within the last 3 months * 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) * 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
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What it tests

  • Stereotactic Arrhythmia Radiotherapy
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Where

1 site
Amsterdam UMC location University of Amsterdam
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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