VT ART Consortium: Radioablation for Ventricular Tachycardia

NCT06922214 | Active Not Recruiting DMC

• 1 other identifier: 0001221/24
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.

Conditions

Ventricular Tachycardia (VT)

Keywords

Radioablation; Ventricular Tachycardia; STAR

Outcome Measures

Primary Outcomes (1)

• Change in the number of VT episodes

  The primary endpoint will be The reduction in VT episodes compared with the pre-treatment period as reported by ICD assessment at follow-up within 12 months after enrollment. The number of VT episodes during the last 3 months before treatment will be compared with the number of VT episodes recorded in a 3-month period after the 'blanking period' thus during the 4th, 5th and 6th months.

  Starting from the week after treatment until 6 months later

Secondary Outcomes (3)

• Change in patient management

  Starting from the week after treatment until 6 months later

• Change in the dosage of antiarrhythmic drugs

  Starting from the week after treatment until 6 months later

• Change in cardiac parameters

  Starting from the week after treatment until 6 months later

Study Arms (1)

Refractory ventricular tachycardia patients

EXPERIMENTAL

Patients with refractory VT as defined above 1. age \> 18 years 2. ICD patients for follow-up 3. Not eligible for heart transplantation. 4. Prognosis not less than 1 year. They will have an initial assessment to verify that condition met the inclusion criteria required for participation, such as.It will be performed * 12-lead ECG * Echocardiography * CT scan of the chest * Laboratory analysis: NT proBNP, HS Troponin I * PMK device evaluation and clinical ECG storage. They will undergo stereotactic treatment on the arrhythmogenic cardiac site

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

SBRT ( 25 Gy single fractions at isodose 80%) on the area responsible of ventricular tachicardia

Also known as: Ventricular Radioablation

Refractory ventricular tachycardia patients

Eligibility Criteria

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

You may qualify if:

• Patients with refractory VT
• age \> 18 years
• Patients with ICDs for follow-up
• Ineligible for heart transplantation.
• Prognosis of not less than 1 year
• Ability to express autonomous consent to therapies or (in case of inability due to clinical condition) deferred consent (first indicated by the referring clinician, later expressed by the patient once recovered to autonomous condition

You may not qualify if:

• Evaluation of ICD demonstrating polymorphic VT;
• Patients with INTERMACS class greater than 4;
• Patients with LVAD;
• Patients with active neoplastic disease undergoing oncological treatment.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli IRCSS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Francesco Cellini

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: November 26, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2029
• Last Updated: May 11, 2025

Record last verified: 2025-03

Locations

IT (1)