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

NCT06294782 | Recruiting

• 1 other identifier: 36/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

STereotactic Arhythmia Radioablation (STAR)

EXPERIMENTAL

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)

Interventions

STereotactic Arhythmia Radioablation (STAR) RADIATION

STereotactic Arhythmia Radioablation (STAR)

STereotactic Arhythmia Radioablation (STAR)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Optimized medical treatment for the underlying SHD
• ICD or CRT-D recipient
• ≥ 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

You may not qualify if:

• Age \< 18 or \> 85 years.
• Inability to provide informed consent.
• Acute myocardial infarction or recent primary coronary intervention or cardiac surgery (\<3 months)
• Primary electrical disease (e.g. long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome).
• Reversible and/or treatable cause of VT (e.g., drug-induced or intoxication)
• ICD electrode malfunction or ICD readings outside reference range
• Pregnancy or breast feeding
• Patients with polymorphic VT/VF

Sponsors & Collaborators

• University of Turin, Italy: lead
• Azienda USL Reggio Emilia - IRCCS: collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

University of Turin

Turin, Italy

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gaetano Maria De Ferrari, MD

CONTACT

+390116336022; gaetanomariadeferrari@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: March 6, 2024
• Study Start: April 15, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

IT (1)