Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06669299

The Value of Late Non-Invasive Programmed Stimulation (NIPS) in Ventricular Tachycardia Ablation to Guide Subsequent Therapeutic Strategies: A Prospective Randomized Multicenter Study

Led by IRCCS Ospedale San Raffaele · Updated on 2026-03-27

51

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the role of non-invasive programmed stimulation (NIPS) in predicting the risk of ventricular tachycardia (VT) recurrence after catheter ablation and to identify the best treatment approach. It focuses on whether a new VT ablation guided by NIPS results can better reduce VT recurrence compared to antiarrhythmic drug therapy. The study is a prospective, randomized, multicenter trial involving patients with structural heart disease and implanted defibrillators. Participants will be randomized into two groups: one receiving antiarrhythmic drug therapy (amiodarone, sotalol, or mexiletine) and the other undergoing a repeat VT ablation procedure based on NIPS findings. The ablation involves programmed ventricular stimulation, mapping, VT induction, and catheter ablation targeting VT sources. The drug therapy group will either restart or start antiarrhythmic medications per clinical practice. The study compares these approaches starting 3 to 7 days after an initial successful ablation. During the study, participants will be monitored for VT recurrence over 12 months, with assessments including ICD shocks, VT storms, hospitalizations for VT or heart failure, and cardiac mortality at procedural and follow-up time points. The main outcome measured is the VT recurrence-free survival rate one year after the procedure. Participants will have regular evaluations and follow-ups to track their heart rhythm status and treatment effects throughout the study duration.

CONDITIONS

Brief Title

Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with an implanted ICD (all brands)
  • Patients who underwent a successful VT ablation procedure supported by EnSite Precision or CARTO 3D mapping systems for the following causes: previous myocardial infarction, myocarditis, arrhythmogenic right ventricular dysplasia, idiopathic dilated cardiomyopathy
  • Induction of monomorphic VT at NIPS 3-7 days after the successful ablation
  • Age 18 years or older
  • Able to provide informed consent and available for study assessments
Not Eligible

You will not qualify if you...

  • Inducible VT after the index procedure
  • Contraindication to anticoagulants
  • Presence of thrombi
  • Presence of mitral and aortic prosthetic valves
  • Recent (less than 3 months) myocardial infarction, unstable angina, or coronary artery bypass
  • Pregnant or nursing
  • Ventricular tachycardia caused by reversible pathology
  • Life expectancy less than 1 year according to investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Procedure and subsequent drug therapy as clinically indicated

Participants undergo either a Re-Do ventricular tachycardia ablation procedure or receive antiarrhythmic drug therapy to manage ventricular tachycardia.

1 to 2 visits depending on treatment allocation

Follow-up

Duration - Up to 12 months after the procedure

Participants are monitored for ventricular tachycardia recurrence and other clinical outcomes following the treatment phase.

Visits at procedural, periprocedural, 6 months, and 12 months after procedure

Trial Site Locations

Total: 1 location

1

San Raffaele Hospital, Arrhythmology and Electrophysiology unit

Milan, Italy, Italy, 20132

Actively Recruiting

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Research Team

A

Andrea Radinovic, MD

A

Anna Montagna, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study.

Paolo Della Bella, Giovanni Peretto, Gabriele Paglino...

https://pubmed.ncbi.nlm.nih.gov/32599177

Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping.

Tadanobu Irie, Ricky Yu, Jason S Bradfield...

https://pubmed.ncbi.nlm.nih.gov/25740836

Defining the Outcome of Ventricular Tachycardia Ablation: Timing and Value of Programmed Ventricular Stimulation.

Teresa Oloriz, Francesca Baratto, Nicola Trevisi...

https://pubmed.ncbi.nlm.nih.gov/29545359