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
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