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.
Implantation of a transvenous pacemaker with active lead fixation.
Implantation of a transvenous implantable cardioverter-defibrillator (ICD) with active lead fixation.
Pregnancy.
Age under 18 years.
Implantation of a subcutaneous ICD (S-ICD).
Implantation of a leadless pacemaker.
Patients admitted to the hospital with an indication for scheduled or urgent transvenous pacemaker or implantable cardioverter-defibrillator (ICD) implantation with active lead fixation
Cohort
Prospective
Not listed
Slew rate value of active fixation leads (pacing or defibrillator leads) measured at the time of implantation
The slew rate value of active fixation leads (pacing or defibrillator leads) measured at the time of implantation will be automatically measured in millivolts (mV) using a Medtronic pacing system analyzer (PSA) (Model 2290) prior to helix deployment for active lead fixation. Both pacemaker and implantable cardioverter-defibrillator (ICD) leads will be included in the study. The lead fixation site (right ventricular apex or septum) and the implantation approach (traditional pacing or conduction system pacing) will be determined at the physician's discretion.
Current of injury of active fixation leads (pacing or defibrillator leads) measured at the time of implantation
Characteristics of the current of injury-including total intracardiac EGM duration (msec), maximum ST elevation (mm), and maximum ST elevation 80 msec after the first EGM deflection (mm)-will be manually measured using the Medtronic PSA Model 2290 immediately after helix deployment during implantation
Sensing of active fixation leads (pacing or defibrillator leads)
Sensing (mV) will be automatically measured using the PSA 2290 before and after helix deployment, as well as after lead fixation, followed by assessment via the device programmer at the end of the implant procedure and prior to discharge. During scheduled device interrogation visits at 1 and 12 months post-implant, sensing will be evaluated automatically using the device programmer.
Capture threshold of active fixation leads (pacing or defibrillator leads)
Capture threshold (volts with a fixed impulse duration of 0.4 msec) will be manually measured using the PSA 2290 before and after helix deployment, as well as after lead fixation. This will be followed by assessment via the device programmer at the end of the implant procedure and prior to discharge. During scheduled device interrogation visits at 1 and 12 months post-implant, capture threshold will be manually evaluated using the device programmer.
Impedance of active fixation leads (pacing or defibrillator leads)
Impedance (ohm) will be automatically measured using the PSA 2290 before and after helix deployment, as well as after lead fixation, followed by assessment via the device programmer at the end of the implant procedure and prior to discharge. During scheduled device interrogation visits at 1 and 12 months post-implant, impedance will be evaluated automatically using the device programmer.
Lead dislodgement
Any lead dislodgement (0 = No; 1 = Yes) occurring within the first 12 months post-implantation will be documented
Significant variation in electrical parameters
Any significant variation in electrical parameters occurring within the first 12 months post-implantation during follow-up will be documented, defined as follows: Pacing threshold: increase of \>1.5 V (with a fixed impulse duration of 0.4 msec) Sensing: decrease to \<4 mV Impedance: increase to \>1500 ohms
Click on the lead sponsor to view all of their trials.
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
