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

NCT06669299 | Recruiting

• 1 other identifier: NIPS
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia (VT)

Keywords

Ventricular Tachycardia, VT, Non-Invasive Programmed Stimulation, NIPS, ICD, Implantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (1)

• VT recurrence free survival rate

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

  12 months after the procedure

Secondary Outcomes (4)

• Number of ICD shocks

  Procedural, periprocedural, 6 and 12 months after procedure

• Proportion of patients with VT storm

  Procedural, periprocedural, 6 and 12 months after procedure

• Rate of subsequent hospitalization for VT recurrence/HF.

  Procedural, periprocedural, 6 and 12 months after procedure

• Cardiac mortality

  Procedural, periprocedural, 6 and 12 months after procedure

Study Arms (2)

Group 1

EXPERIMENTAL

AAD therapy

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

Group 2

EXPERIMENTAL

Re-Do ablation procedure

Procedure: Re-Do ventricular tachycardia ablation

Interventions

Re-Do ventricular tachycardia ablation PROCEDURE

1\. 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.

Group 2

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

San Raffaele Hospital, Arrhythmology and Electrophysiology unit

Milan, Italy, 20132, Italy

RECRUITING

Related Publications (4)

• Della Bella P, Peretto G, Paglino G, Bisceglia C, Radinovic A, Sala S, Baratto F, Limite LR, Cireddu M, Marzi A, D'Angelo G, Vergara P, Gulletta S, Mazzone P, Frontera A. Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study. Heart Rhythm. 2020 Dec;17(12):2111-2118. doi: 10.1016/j.hrthm.2020.06.025. Epub 2020 Jun 26.

  PMID: 32599177 RESULT

• Irie T, Yu R, Bradfield JS, Vaseghi M, Buch EF, Ajijola O, Macias C, Fujimura O, Mandapati R, Boyle NG, Shivkumar K, Tung R. Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):390-9. doi: 10.1161/CIRCEP.114.002637. Epub 2015 Mar 4.

  PMID: 25740836 RESULT

• Muser D, Hayashi T, Castro SA, Supple GE, Schaller RD, Santangeli P, Arkles J, Kumareswaran R, Nazarian S, Deo R, Lin D, Dixit S, Epstein AE, Callans DJ, Marchlinski FE, Frankel DS. Noninvasive Programmed Ventricular Stimulation-Guided Management Following Ventricular Tachycardia Ablation. JACC Clin Electrophysiol. 2019 Jun;5(6):719-727. doi: 10.1016/j.jacep.2019.03.007. Epub 2019 May 1.

  PMID: 31221360 RESULT

• Oloriz T, Baratto F, Trevisi N, Barbaro M, Bisceglia C, D'Angelo G, Yamase M, Paglino G, Radinovic A, Della Bella P. Defining the Outcome of Ventricular Tachycardia Ablation: Timing and Value of Programmed Ventricular Stimulation. Circ Arrhythm Electrophysiol. 2018 Mar;11(3):e005602. doi: 10.1161/CIRCEP.117.005602.

  PMID: 29545359 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Amiodarone; Sotalol; Mexiletine

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propylamines; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Andrea Radinovic, MD

CONTACT

+39 0226436316; radinovic.andrea@hsr.it

Anna Montagna, PhD

CONTACT

+39 0226437489; montagna.anna@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 1, 2024
• Study Start: June 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)