Stereotactic radiotherapy for treating ventricular tachycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of stereotactic arrhythmia radiotherapy (STAR) in patients with therapy-refractory ventricular tachycardia (VT). It is a single-arm, monocenter, pre-post intervention study that aims to assess the impact of STAR on electro-anatomical alterations in the heart. Patients will receive a single dose of 25 Gy targeted at the pro-arrhythmic cardiac region using standard stereotactic techniques. The study also seeks to understand the underlying mechanisms of action of this treatment modality.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam UMC location University of Amsterdam
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Pieter G Postema, MD PhD — University of Amsterdam
• Study coordinator: Pieter G Postema, MD PhD
• Email: p.g.postema@amsterdamumc.nl
• Phone: 0031 20 566 4338

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.