Slew Rate As a Predictor for Optimal Lead Fixation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorPaolo Pastori, MD

About this trial

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.

Eligibility criteria

Qualifiers

Implantation of a transvenous pacemaker with active lead fixation.

Implantation of a transvenous implantable cardioverter-defibrillator (ICD) with active lead fixation.

Disqualifiers

Pregnancy.

Age under 18 years.

Implantation of a subcutaneous ICD (S-ICD).

Implantation of a leadless pacemaker.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

516 Participants
are grouped into 1 trial group

Sponsors and collaborators

Paolo Pastori, MD

Lead sponsor

Azienda Unità Sanitaria Locale di Parma

Sponsor institution

University Hospital of Ferrara

Collaborator

Azienda USL Reggio Emilia - IRCCS

Collaborator

Azienda Unita Sanitaria Locale di Piacenza

Collaborator