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

NCT ID: NCT06294782

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

STereotactic Arhythmia Radioablation (STAR)

Intervention Type: RADIATION

STereotactic Arhythmia Radioablation (STAR)

Interventions

STereotactic Arhythmia Radioablation (STAR)

STereotactic Arhythmia Radioablation (STAR)

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Turin

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gaetano Maria De Ferrari, MD

Role: CONTACT

gaetanomariadeferrari@unito.it

+390116336022

Facility Contacts

Gaetano Maria De Ferrari

Role: primary

Other Identifiers

36/2022

Identifier Type: -

Identifier Source: org_study_id