Cohort study on radioablation for difficult-to-treat ventricular tachycardia
PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia
This study is testing if a special treatment called radioablation can help people with hard-to-treat ventricular tachycardia feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Locations | 1 site (Turin) |
| Trial ID | NCT06294782 on ClinicalTrials.gov |
What this trial studies
This multicenter interventional study aims to enroll patients with refractory ventricular tachycardia who meet specific inclusion criteria over a 33-month period. It allows for the inclusion of retrospective patients who have previously undergone stereotactic arrhythmia radioablation (STAR) if they meet all criteria and consent to participate. All enrolled patients will follow a standardized investigation protocol, including standardized programming of implantable cardioverter-defibrillators (ICDs). The study seeks to evaluate the effectiveness of STAR in managing this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 with structural heart disease and a history of sustained or treated monomorphic ventricular tachycardia resistant to previous ablation attempts.
Not a fit: Patients with primary electrical diseases or those who have reversible causes of ventricular tachycardia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with refractory ventricular tachycardia, potentially improving their quality of life and reducing the risk of life-threatening arrhythmias.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in the management of refractory ventricular tachycardia, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Turin
- University of Turin — Turin, Italy (Recruiting)
Study contacts
- Study coordinator: Gaetano Maria De Ferrari, MD
- Email: gaetanomariadeferrari@unito.it
- Phone: +390116336022
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.