StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2

Recruiting now · Phase 2

Conditions studied: Ventricular Tachycardia, Arrythmia, Cardiac

In brief

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.

Key facts

Study ID

NCT05439031

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

12

Starts

2023-05-19

Expected to finish

2027-07-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnancy
• History of radiation treatment in the thorax or upper abdominal region
• Interstitial pulmonary disease

Where it is running

• Amsterdam UMC location University of Amsterdam — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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