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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory Ventricular Tachycardia
• Intervention / Treatment: Radiation: STereotactic Arhythmia Radioablation (STAR)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaetano Maria De Ferrari, MD; Phone Number: +390116336022; Email: gaetanomariadeferrari@unito.it

Study Locations

• Italy
  • Turin, Italy
    • Recruiting
    • University of Turin
    • Contact: Gaetano Maria De Ferrari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STereotactic Arhythmia Radioablation (STAR); Patients fulfilling the inclusion and exclusion criteria will undergo (or already underwent) a single-session 25 Gy STAR for the treatment of refractory monomorphic VT.	Radiation: STereotactic Arhythmia Radioablation (STAR); STereotactic Arhythmia Radioablation (STAR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 36/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No