NCT05439031 StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2
| NCT ID | NCT05439031 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Ventricular Tachycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2023-05-19 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Pieter G Postema, MD PhD
PRINCIPAL INVESTIGATOR
University of Amsterdam
Frequently Asked Questions
Who can join the NCT05439031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Tachycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05439031 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05439031 currently recruiting?
Yes, NCT05439031 is actively recruiting participants. Contact the research team at p.g.postema@amsterdamumc.nl for enrollment information.
Where is the NCT05439031 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05439031 clinical trial?
NCT05439031 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Pieter G Postema, MD PhD at University of Amsterdam. The trial plans to enroll 12 participants.