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Active, Not Recruiting

NCT Number: NCT06922214

VT ART Consortium: Radioablation for Ventricular Tachycardia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ventricular Tachycardia (VT) Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Universitario Agostino Gemelli IRCSS

Rome, RM, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Stereotactic Body Radiation Therapy (SBRT)

Radiation

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

Other names: Ventricular Radioablation

Primary outcomes

  1. Change in the number of VT episodes

    Time frame: Starting from the week after treatment until 6 months later

    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.

Secondary outcomes

  1. Change in patient management

    Time frame: Starting from the week after treatment until 6 months later

    Reduction in VT episodes compared with the pre-treatment period as reported by ICD query in the shortest observational period. In more detail: the number of VT episodes in the last month before treatment will be compared with the number of VT episodes recorded in the third (3rd) month after treatment.

  2. Change in the dosage of antiarrhythmic drugs

    Time frame: Starting from the week after treatment until 6 months later

    Total reduction/suspension of antiarrhythmic drugs compared with baseline (before radiotherapy).

  3. Change in cardiac parameters

    Time frame: Starting from the week after treatment until 6 months later

    Improvement in cardiac parameters compared with baseline: LVEF, left ventricular diastolic volume

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

VT-ART-P: Ventricular Tachycardia Ablation and RadioTherapy, a Prospective Study

Acronym: VT-ART-P

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Apr 10, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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