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Late Non-Invasive Programmed Stimulation for Ventricular Tachycardia Ablation Strategy

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What is being tested

Re-Do ventricular tachycardia ablation

+ Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)

ProcedureDrug
Who is being recruted

Cardiac Conduction System Disease+5

+ Arrhythmias, Cardiac

+ Cardiovascular Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorIRCCS Ospedale San Raffaele
Study ContactAndrea Radinovic, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleThe Value of Late Non-Invasive Programmed Stimulation (NIPS) in the Setting of Ventricular Tachycardia (VT) Ablation to Guide the Subsequent VT Therapeutic Strategies: a Prospective Randomized Multicenter Study
Principal SponsorIRCCS Ospedale San Raffaele
Study ContactAndrea Radinovic, MDMore contacts
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

51 patients to be enrolled

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

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



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

5 inclusion criteria required to participate
Patients with an implanted ICD (all brands)

Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM.

Induction of monomorphic VT at NIPS 3-7days after a successful index procedure

Age 18 years or more

Show More Criteria

8 exclusion criteria prevent from participating
Inducible VT after index procedure

Contraindication to anticoagulants

Presence of thrombi

Presence of Mitral and Aortic prosthetic valve

Show More Criteria

Study Plan

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

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Re-Do ablation procedure

Group II

Experimental
AAD therapy

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

San Raffaele Hospital, Arrhythmology and Electrophysiology unit

Milan, ItalyOpen San Raffaele Hospital, Arrhythmology and Electrophysiology unit in Google Maps
Recruiting soonOne Study Center