Late Non-Invasive Programmed Stimulation for Ventricular Tachycardia Ablation Strategy
Re-Do ventricular tachycardia ablation
+ Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)
Cardiac Conduction System Disease+5
+ Arrhythmias, Cardiac
+ Cardiovascular Diseases
Prevention Study
Summary
Study start date: December 31, 2024
Actual date on which the first participant was enrolled.This study focuses on evaluating a method called non-invasive programmed ventricular stimulation (NIPS) in patients who have undergone a procedure called ablation for ventricular tachycardia (VT), a condition related to irregular heart rhythms, especially in those with existing heart disease. The main goal is to understand whether a second ablation procedure, called a "Re-Do," could be more effective than standard medical treatments in preventing the return of VT. This research is important because previous findings suggest that some patients might still be at risk of VT recurrence despite initial successful treatment, and understanding the best approach to manage this risk can improve patient outcomes. In the study, participants will have their heart's response to programmed stimulation assessed using their Implantable Cardioverter-Defibrillator (ICD) device. This assessment will determine if VT can still be triggered in the days following the initial ablation. Participants will be randomly assigned to either receive a second ablation procedure or to continue with standard medical care, depending on their results from the NIPS. The study will compare the rates of VT recurrence between these two groups to determine which approach is more effective. The potential benefit of participating is a more tailored treatment plan that could reduce the likelihood of VT returning, although there are risks associated with undergoing additional procedures.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.51 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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
San Raffaele Hospital, Arrhythmology and Electrophysiology unit
Milan, ItalyOpen San Raffaele Hospital, Arrhythmology and Electrophysiology unit in Google Maps