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Slew Rate As a Predictor for Optimal Lead Fixation

NCT06842940 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 516

Last updated 2025-02-24

No results posted yet for this study

Summary

The goal of this observational study is to identify the most reliable electrical parameter measured at the time of implantation that can predict optimal lead fixation and long-term lead performance in patients undergoing transvenous pacemaker or implantable cardioverter-defibrillator (ICD) implant.

The main questions it aims to answer are:

* Is there a correlation between the slew rate measured at the time of lead implantation and the sensing measured at the 12-month follow-up?
* Is there a correlation between all electrical parameters recorded at implantation (including slew rate, current of injury, acute sensing, acute impedance, and acute pacing threshold) and the electrical parameters assessed at 12 months post-implantation (specifically chronic sensing, chronic impedance, and chronic pacing threshold)? Participants will undergo regular follow-up evaluations, with device interrogation visits scheduled at 1 and 12 months post-implantation as part of routine clinical care.

Conditions

  • Defibrillators, Implantable
  • Electrodes, Implanted
  • Pacemaker, Artificial
  • Predictive Value of Tests

Sponsors & Collaborators

  • University Hospital of Ferrara

    collaborator OTHER

  • Azienda USL Reggio Emilia - IRCCS

    collaborator OTHER_GOV

  • Azienda Unita Sanitaria Locale di Piacenza

    collaborator OTHER

  • Paolo Pastori, MD

    lead OTHER

Principal Investigators

  • Paolo Pastori, MD · Cardiology Unit, Medical and Diagnostics Department, Fidenza Hospital, Azienda USL of Parma

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-18
Primary Completion
2026-02-28
Completion
2027-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842940 on ClinicalTrials.gov