Suspended

VT-ART-PVentricular Tachycardia Ablation and Radiotherapy for Improved Heart Function

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What is being tested

Stereotactic Body Radiation Therapy (SBRT)

Radiation
Who is being recruted

Cardiac Conduction System Disease+5

+ Arrhythmias, Cardiac

+ Cardiovascular Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 26, 2024

Actual date on which the first participant was enrolled.

This study aims to explore new treatment options for patients suffering from ventricular tachycardia, a condition where the heart beats faster than normal. The research focuses on using a combination of heart procedures and radiotherapy to potentially reduce the number of fast heartbeat episodes. This study is important because it may help decrease the need for medications used to control heart rhythms, improve heart function, and enhance the overall quality of life for patients living with this condition. Understanding these potential benefits is crucial for developing better treatment strategies for those affected by ventricular tachycardia. Participants in the study will undergo a series of initial tests to ensure they meet the study requirements. These tests include an ECG, an ultrasound of the heart, a chest CT scan, and various blood tests. The study will last for 60 months and involves 52 patients. Although participants will not incur any costs or receive any payment, there are some risks, such as inflammation around the heart, lung issues, worsening heart failure, or even death. However, there is hope that participants will experience fewer episodes of fast heartbeats, a reduction or complete stop of heart rhythm drugs, improved heart function, and a better quality of life. The study is carefully designed to gather valuable information that could lead to advancements in treating ventricular tachycardia.

Official TitleVT-ART-P: Ventricular Tachycardia Ablation and RadioTherapy, a Prospective Study
NCT06922214
Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiac Conduction System DiseaseArrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaTachycardia, Ventricular

Criteria

6 inclusion criteria required to participate
Patients with refractory VT

age > 18 years

Patients with ICDs for follow-up

Ineligible for heart transplantation.

Show More Criteria

4 exclusion criteria prevent from participating
Evaluation of ICD demonstrating polymorphic VT;

Patients with INTERMACS class greater than 4;

Patients with LVAD;

Patients with active neoplastic disease undergoing oncological treatment.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Policlinico Universitario Agostino Gemelli IRCSS

Rome, ItalyOpen Policlinico Universitario Agostino Gemelli IRCSS in Google Maps
SuspendedOne Study Center
VT-ART-P | Ventricular Tachycardia Ablation and Radiotherapy for Improved Heart Function | PatLynk