Stereotactic radiotherapy for treating ventricular tachycardia
StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2
PHASE2 · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05439031
This study is testing if a special type of targeted radiation therapy can help people with hard-to-treat ventricular tachycardia feel better and improve their heart health.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05439031 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with an implanted ICD and a history of recurrent VT despite previous treatments.
Not a fit: Patients who are pregnant, have a history of thoracic radiation treatment, or suffer from interstitial pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of VT episodes and improve the quality of life for patients with refractory arrhythmias.
How similar studies have performed: Previous studies have shown promising results with stereotactic arrhythmia radiotherapy, indicating a significant reduction in VT episodes.
Eligibility criteria
Show full inclusion / exclusion 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, 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 this trial is running
Amsterdam, North Holland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventricular Tachycardia, Arrythmia, Cardiac, Ventricular Arrhythmias, Cardiac Radioablation, Stereotactic Radiotherapy, Stereotactic Arrhythmia Radiotherapy, Stereotactic body radiotherapy, Cardiac ablative radiotherapy