PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia

Launched by UNIVERSITY OF TURIN, ITALY · Mar 4, 2024

Keywords

ClinConnect Summary

The STAR clinical trial is studying a treatment called Stereotactic Arhythmia Radioablation (STAR) for patients with a heart condition known as refractory ventricular tachycardia (VT), where the heart beats too fast and can be difficult to control. This study aims to enroll patients over about 33 months, including some who have already received STAR treatment in the past. Participants will undergo a series of standardized tests to assess their condition and treatment response.

To be eligible for this trial, patients generally need to be between 65 and 85 years old, have structural heart disease (like weakened heart muscles), and have experienced at least one episode of this fast heartbeat that hasn't responded well to previous treatments. They should also have a heart device called an ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy Defibrillator). Throughout the trial, participants can expect to receive monitored care and standardized programming of their heart devices. It's important to note that certain individuals may not qualify for the study, such as those with specific heart rhythm disorders or recent heart surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Structural heart disease (SHD) defined as left ventricular dysfunction (LVEF \< 55%), or right ventricular dysfunction (FAC \<35%) or presence of ventricular scar, pathological hypertrophy, wall bulging or inflammatory conditions.
• • 2. Optimized medical treatment for the underlying SHD
• • 3. ICD or CRT-D recipient
• • 4. ≥ 1 episodes of sustained or treated (with either anti-tachycardia pacing or shock, internal or external) monomorphic VT (MMVT) resistant to at least one invasive VT ablation attempt, unless contraindicated or deemed at high risk. Reason for lack of ablation must be specified
• Exclusion Criteria:
• • 1. Age \< 18 or \> 85 years.
• • 2. Inability to provide informed consent.
• • 3. Acute myocardial infarction or recent primary coronary intervention or cardiac surgery (\<3 months)
• • 4. Primary electrical disease (e.g. long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome).
• • 5. Reversible and/or treatable cause of VT (e.g., drug-induced or intoxication)
• • 6. ICD electrode malfunction or ICD readings outside reference range
• • 7. Pregnancy or breast feeding
• • 8. Patients with polymorphic VT/VF