VT ART Consortium: Radioablation for Ventricular Tachycardia

NCT ID: NCT06922214

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-26
• Study Completion Date: 2029-10-31

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.

Detailed Description

By agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. At that visit,

• 12-lead ECG will be performed
• Echocardiography
• CT scan of the chest
• Laboratory tests: NT proBNP, HS Troponin I
• PMK device evaluation The study will have a duration of 60 months and will involve 52 patients with the same disease from which one is affected. Specifically, the total expected duration of individual subject participation in the study will be 60 months.

Participation in the study does not involve any expense for the patient or any compensation.

Participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus.

The following benefits can be expected from participation in this study: reduction of VT episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : LVEF, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, RVEF and TAPSE for right ventricular function, improvement of patient's quality of life (SF-36) compared to baseline. No direct benefits may also emerge from the study, but still significant for research.

Conditions

Ventricular Tachycardia (VT)

Study Design

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

Study Groups

Refractory ventricular tachycardia patients

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

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

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

Interventions

Stereotactic Body Radiation Therapy (SBRT)

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

Intervention Type: RADIATION

Other Intervention Names

Ventricular Radioablation

Eligibility Criteria

Inclusion Criteria

1. Patients with refractory VT

2. age > 18 years

3. Patients with ICDs for follow-up

4. Ineligible for heart transplantation.

5. Prognosis of not less than 1 year

6. 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

Exclusion Criteria

1. Evaluation of ICD demonstrating polymorphic VT;

2. Patients with INTERMACS class greater than 4;

3. Patients with LVAD;

4. Patients with active neoplastic disease undergoing oncological treatment.

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

CELLINI FRANCESCO

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Cellini

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Policlinico Universitario Agostino Gemelli IRCSS

Rome, RM, Italy

Countries

Italy

Other Identifiers

0001221/24

Identifier Type: -

Identifier Source: org_study_id