Clinical Research Directory

Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia

This will be a single arm study evaluating a new ablation technology for performing catheter ablation of ventricular tachycardia. The technology combines novel pulsed field ablation with radiofrequency ablation.

Imaging and Treatment Planning for Cardiac Radioablation

Cardiac radioablation is a new treatment for ventricular tachycardia (VT), which uses beams of radiation to treat heart scar that causes VT. To identify the scar areas, magnetic resonance imaging (MRI) and computed tomography (CT) imaging are often used. These are both types of medical imaging that allow clinicians to examine scar area without having to do invasive surgery. Researchers have developed new heart imaging protocols using both MRI and CT. Their MRI protocol method can now spot both dense and scattered scar tissue. The CT protocol combines multiple different types of scans into a single appointment and uses a special scanner that captures the motion of the heart. For this study, patients will undergo CT and MRI imaging according to these new imaging protocols. With this study, researchers aim to show that these new imaging protocols can be undergone by patients with ventricular tachycardia and can be used to identify scar. Researchers will also use these scans to make radiation treatment plans to identify which types of treatment can be delivered safely to patients.

Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia

The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).

Proton Radiosurgery for the Treatment of Malignant Ventricular Tachyarrhythmias

Ventricular arrhythmias (VAs) are the leading cause of sudden cardiac death (SCD) worldwide. The implantable defibrillator (ICD) increases survival in patients at risk of VA, with data of superiority to antiarrhythmic drugs. Nevertheless, the ICD cannot prevent VAs, and shocks delivered by the device (appropriate and inappropriate) negatively impact patients' quality of life. Transcatheter ablation (TCA) is the percutaneous therapy that can eliminate VAs and prevent any recurrence. TCA is the state of the art for the treatment of drug-unresponsive VAs in patients with structural heart disease, but the prevalence of recurrence remains high (between 30% and 60%). For these reasons, several reports have recently appeared in the literature proposing a new solution for the treatment of VAs in which the use of external-beam body radiotherapy with stereotactic-radiosurgical technique (SBRT) is described. SBRT represents a rapid, noninvasive approach based on the delivery of high radiation doses of photons (25 Gy in a single fraction) to a precise location in cardiac tissue. SBRT has entered the latest 2022 European Society of Cardiology (ESC) guidelines on VAs as a "bailout therapy". Based on preliminary data in the oncology setting, proton therapy could allow further optimization of compliance of these therapeutic doses by preserving even more of the healthy heart part and thus reducing the cardiopulmonary toxicity of radiotherapy outside the ablation target. The investigators therefore propose an experimental (prospective interventional) study to evaluate the toxicity (primary endpoint) and efficacy (secondary endpoint) of proton radiosurgery for the treatment of VA with an enrollment of 21 patients. The primary endpoint is to evaluate the toxicity of proton radiotherapy in the acute phase (during the first 30 days of the procedure) and at 3, 6 and 12 months. A crucial part of the protocol will be the proper definition of the target to be irradiated, which will require the integration of different non-invasive cardiac imaging methodologies such as CT (Computed Tomography), MRI (Magnetic Resonance Imaging) and PET (Positron Emission Tomography), coupled with invasive and/or "non-invasive" body surface mapping with multi-electrode electrocardiogram (ECG) so as to obtain a "cardiac image" in which the myocardial scar and the arrhythmogenic region are fused.