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NCT Number: NCT06669299

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

The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The value of non-invasive programmed ventricular stimulation (NIPS) in the setting of ablation of ventricular tachycardia (VT) in patients with structural heart disease has been the object of studies in the last decade.

The technique is based on the feature, uniformly available in the Implantable Cardioverter-Defibrillator (ICD), to perform a complete programmed stimulation study from the apex of the right ventricle to assess the inducibility of ventricular tachycardia, similar to what is routinely performed during an invasive electrophysiology procedure. Data from our group indicate that 26% of patients who were non-inducible (apparent success) at the end of the ablation session become re-inducible to ventricular tachycardia at "late" NIPS (day 6). This finding, possibly related to partial recovery of conduction within the treated area, had prognostic significance, as it was associated with a 6-fold increased risk of VT recurrence at follow-up.

Recently Muser et al. reported similar findings (45/216 -21% of patients had clinical VT induced) with "late" NIPS performed on day 3. However, within this group of patients, the VT recurrence rate was significantly lower in those who had undergone, based on this finding, a re-do VT ablation as compared to those treated conservatively (rec in 1/11 of the Re-do ablation group, 9% vs. 24/34 in the conservative treatment group, 71%, p<0.01).

These data, however, originated from a retrospective observational analysis, where the indication of ablation was based on empirical physician preference.

No prospective randomized data compare the conservative attitude versus performing a new ablation in subjects who did not obtain a stable result after the first one. Therefore, this randomized multicenter clinical study aims to evaluate whether the repetition (Re-Do) of VT ablation process is superior to conservative medical therapy for reducing VT recurrences on post-procedural NIPS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol.

Exclusion criteria

  • Inducible VT after index procedure
  • Contraindication to anticoagulants
  • Presence of thrombi
  • Presence of Mitral and Aortic prosthetic valve
  • Recent (<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
  • Pregnant or nursing
  • Ventricular Tachycardia caused by reversible pathology
  • < 1 Year life expectancy according to the investigator

Treatment and study plan

Re-Do ventricular tachycardia ablation

Procedure
  • Programmed ventricular stimulation (PVS); 2. Mapping during Sinus Rhythm (SR) or right ventricular pacing in pacing dependent patients; 3. Late Potentials identification; 4. VT(s) induction with diastolic pathway mapping when possible; 5. Catheter Ablation in SR or, at the operator's discretion, in VT if tolerated by the patient; 6. If VT is not inducible or the diastolic pathway is not mappable, a substrate ablation approach will be performed. 7. PVS is repeatedly attempting to reinduce VT after completing; 8. Endpoint: non-inducibility of any VT.

Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)

Drug

The patients with a positive NIPS already on antiarrhythmic drugs (AAD) before the index procedure will re-start the original antiarrhythmic therapy. Patients who were not on AAD will start a new drug at the operator's discretion (amiodarone, sotalol, or mexiletine) according to clinical practice.

Primary outcomes

  1. VT recurrence free survival rate

    Time frame: 12 months after the procedure

    Compare the efficacy on the reduction of VT recurrence of a NIPS-based Re-Do VT ablation versus antiarrhythmic drug therapy

Secondary outcomes

  1. Number of ICD shocks

    Time frame: Procedural, periprocedural, 6 and 12 months after procedure

  2. Proportion of patients with VT storm

    Time frame: Procedural, periprocedural, 6 and 12 months after procedure

  3. Rate of subsequent hospitalization for VT recurrence/HF.

    Time frame: Procedural, periprocedural, 6 and 12 months after procedure

  4. Cardiac mortality

    Time frame: Procedural, periprocedural, 6 and 12 months after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Radinovic, MD

CONTACT

[email protected]

+39 0226436316

Anna Montagna, PhD

CONTACT

[email protected]

+39 0226437489

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Registry information

Official study title

The 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Mar 27, 2026

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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