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Search / Trial NCT06669299

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

Launched by IRCCS OSPEDALE SAN RAFFAELE · Oct 30, 2024

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Ventricular Tachycardia, Vt, Non Invasive Programmed Stimulation, Nips, Icd, Implantable Cardioverter Defibrillator

ClinConnect Summary

This clinical trial is looking at a new way to manage a heart condition called Ventricular Tachycardia (VT), which is a fast and potentially dangerous heart rhythm. The study will explore whether a method called Non-Invasive Programmed Stimulation (NIPS) can help doctors better predict the risk of VT returning after a patient has undergone a treatment called catheter ablation. The main goal is to see if using NIPS to guide further treatment can lower the chances of VT coming back, compared to just using medications to manage the condition.

To participate in this study, patients need to be at least 18 years old and have a special device called an ICD (Implantable Cardioverter Defibrillator) already implanted. They should have had a successful VT ablation procedure that made them free of VT, and then have experienced a specific type of VT just a few days later during the NIPS test. However, patients with certain conditions, such as those who recently had a heart attack or have specific heart valves or clots, will not be eligible. Participants in the study can expect to undergo assessments and monitoring to help determine the best treatment strategy for their VT. This trial is currently not recruiting, so it is important to check back for updates if you're interested.

Gender

ALL

Eligibility criteria

  • 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

About Irccs Ospedale San Raffaele

IRCCS Ospedale San Raffaele is a leading research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical knowledge and improving patient care through innovative research. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it integrates clinical practice with cutting-edge scientific research, focusing on a wide range of therapeutic areas including oncology, neurology, and cardiovascular diseases. The institution is dedicated to conducting high-quality clinical trials that adhere to rigorous ethical standards, fostering collaboration among multidisciplinary teams to translate scientific discoveries into effective treatments for patients. Through its robust infrastructure and expertise, IRCCS Ospedale San Raffaele plays a pivotal role in shaping the future of healthcare both nationally and internationally.

Locations

Milan, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported