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

Refractory Ventricular Tachycardia Clinical Trial

— POPSTAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294782
• Other study ID #: 36/2022
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: University of Turin, Italy
• Contact: Gaetano Maria De Ferrari, MD
• Phone: +390116336022
• Email: gaetanomariadeferrari[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractory Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Radiation:
• STereotactic Arhythmia Radioablation (STAR)
STereotactic Arhythmia Radioablation (STAR)

Locations

Country	Name	City	State
Italy	University of Turin	Turin

Sponsors (4)

Lead Sponsor	Collaborator
University of Turin, Italy	Azienda Unità Sanitaria Locale Reggio Emilia, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VT storm and incessant VT	6-month survival free from VT storm (3 or more episodes or sustained or treated VT within 24 hours) and incessant VT (binary endpoint), including an initial blanking period of 8 weeks.	6 months
Primary	adverse events	: measured by registered adverse events using the CTCAE v5 system, 'early' (up to 30 days), 'intermediate' (30-90 days), and 'late' (>90 days after treatment). The extensive mandatory and optional follow-up examinations provide the basis for detecting these adverse events.	33 months