Actively Recruiting
Cardiac RadiothErapy for VEntricular Tachycardia II - a Prospective Observational Cohort Study
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-29
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating long-term outcomes of stereotactic radiotherapy ablation (STAR) in patients with therapy-refractory ventricular tachycardia (VT). This observational study aims to assess both the effectiveness and safety of STAR over an extended period, addressing the need for long-term data in this patient population. The study is sponsored by Universitaire Ziekenhuizen KU Leuven and focuses on people who have VT that has not responded adequately to other treatments. The treatment involves delivering a single dose of 25 to 32.5 Gy of stereotactic radiotherapy to the heart muscle. Participants eligible for STAR are selected based on multidisciplinary discussions. As an observational cohort study, it follows patients after receiving this therapy without assigning treatments randomly. Participants will be followed for up to 48 months, with assessments at baseline and multiple follow-up points to evaluate changes in VT burden, quality of life, heart function, valve disease progression, coronary artery disease, mortality, and radiotherapy-related toxicity. They will provide written consent and agree to return for regular check-ups during the study period to monitor these outcomes.
CONDITIONS
Brief Title
Cardiac RadiothErapy for VEntricular Tachycardia II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for stereotactic radiotherapy ablation (STAR) for therapy-refractory ventricular tachycardia based on multidisciplinary discussion
- Ability to provide written informed consent and willingness to attend follow-up visits
You will not qualify if you...
- Pregnancy or breastfeeding
- Previous radiotherapy involving the heart area
- Life expectancy less than 6 months without ventricular tachycardia
- Any condition considered a contraindication by the investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - Single treatment session
Participants receive a single dose of stereotactic radiotherapy ablation targeting the myocardium for therapy-refractory ventricular tachycardia.
1 visit (in-person) for the radiotherapy ablation procedure
Duration - Up to 48 months
Participants are monitored over time to assess changes in ventricular tachycardia burden, quality of life, cardiac function, valve disease, coronary artery disease, and potential radiotherapy toxicity.
Follow-up visits at 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, and 48 months
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
B
Bert Vandenberk, MD PhD
P
Patrick Berkovic, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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