Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial

Launched by UNIVERSITY OF ZURICH · Oct 21, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on improving treatment for patients with a heart condition called ventricular tachycardia (VT), which is characterized by an unusually fast heart rhythm that can lead to serious health issues. The researchers want to see if giving a higher dose of radiation during treatment can help create lasting scars in the heart tissue, which may prevent the VT from returning. Currently, a single radiation dose of 25 Gy is used, but the study suggests that increasing this dose could lead to better long-term results for patients.

To participate in this trial, you need to be at least 18 years old and have a history of structural heart disease, such as ischemic or non-ischemic cardiomyopathy, along with having had at least one unsuccessful catheter ablation procedure to control the VT. Participants will receive the higher radiation treatment and will be closely monitored to see how effective it is in reducing the recurrence of VT. It's important to know that not everyone will qualify; for example, those with only occasional heartbeats issues or certain medical conditions may be excluded. If you're interested, you'll be provided with detailed information and must give your written consent to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with structural heart disease, in particular ischemic and non-ischemic cardiomyopathy: Implanted ICD and/or CRT-D. Prior ≥1 failed catheter ablation (with endocardial ± epicardial approach based on the substrate location and the ECG morphology of clinical VTs) procedure to control sustained monomorphic VT using currently recommended mapping and ablation techniques,2 or patients in whom ablation is not feasible. Reasons for lack of epicardial ablation and non-feasibility of catheter ablation must be specified. Sustained VT recurrence after catheter ablation on optimised antiarrhythmic medication.
• • Age ≥18 years. IRB-approved, written informed consent must be provided
• Exclusion Criteria:
• • Patients with only premature ventricular contractions.
• Patients with sustained VT/VF who demonstrate:
• • Acute myocardial infarction; Primary electrical disease (channelopathy); Reversible and treatable cause (e.g., drug-induced or intoxication) of VT that can be adequately addressed otherwise; A target that cannot be safely and precisely defined based on stereotactic radiotherapy accuracy requirements (e.g., anatomical interference from OARs, overlapping prior radiation therapy to the thoracic region); Pregnancy or breastfeeding; Inability to provide informed consent.