Clinical trial NCT06842940: Slew Rate As a Predictor for Optimal Lead Fixation
Official title: Evaluating Slew Rate As a Predictor for Optimal Lead Fixation in Transvenous Cardiac Implantable Devices: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Defibrillators, Implantable
Electrodes, Implanted
Pacemaker, Artificial
Predictive Value of Tests
Keywords: pacemaker
implantable cardiac defibrillator
lead
slew rate
sensing
active fixation
electrical performance
Lead sponsor: Azienda Unità Sanitaria Locale di Parma
Sponsor class: OTHER
Collaborators: name: University Hospital of Ferrara
name: Azienda USL Reggio Emilia - IRCCS
name: Azienda Unita Sanitaria Locale di Piacenza
First posted: 2025-02-24
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the hospital with an indication for scheduled or urgent transvenous pacemaker or implantable cardioverter-defibrillator (ICD) implantation with active lead fixation

Brief 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.

Detailed description: During the implantation of transvenous pacemakers and implantable cardiac defibrillators, the placement of active fixation leads requires the measurement of standard electrical parameters (sensing, impedance, and capture threshold) to identify the optimal pacing site before helix deployment into the cardiac muscle. Selecting the optimal site at the time of implantation is crucial to ensure long-term lead performance and to prevente potential device malfunctions secondary to threshold elevation or sensing reduction.

Two additional electrical parameters-slew rate and the current of injury-may aid in selecting the optimal pacing site. However, these parameters have been poorly studied in the literature and exhibit significant differences. While the slew rate is easily measurable, as it is automatically determined by the pacing system analyzer (PSA), the current of injury requires non-standardized, complex, operator-dependent, and time-consuming manual measurements. Additionally, the slew rate can be assessed before helix deployment, whereas the current of injury can only be measured after helix fixation. While the current of injury generally indicates adequate helix fixation, at least in the acute setting, the significance of slew rate in predicting long-term lead stability remains uncertain.

The study hypothesis is that the slew rate significantly correlates with sensed electrical activity at 12 months post-implantation and may therefore serve as a predictor of optimal long-term lead fixation and performance.

This is a prospective, observational, single-arm, investigator-initiated, multicenter, non-profit cohort study. Four Italian centers are participating: Ospedale di Fidenza, Arcispedale Santa Maria Nuova di Reggio Emilia, Ospedale Civile di Piacenza, and Azienda Ospedaliero-Universitaria di Ferrara.

Patients undergoing pacemaker or ICD implantation with active-fixation atrial or ventricular leads, either for pacing or defibrillation, will be enrolled. The lead fixation site (right ventricular apex or septum) and pacing modality (traditional right ventricular pacing or conduction system pacing) will be determined at the physician's discretion.

Electrical parameters at implantation-including slew rate, current of injury, sensing, impedance, and capture threshold-will be measured in all participating centers using the same pacing system analyzer (PSA) model (Medtronic, Model 2290). Slew rate, sensing, impedance, and capture threshold will be assessed before and after helix deployment, as well as after lead fixation.

The current of injury is defined as an increase in ST-segment elevation of at least 5 mV for ventricular leads and 1 mV for atrial leads compared to baseline in the intracardiac electrogram (EGM).

All characteristics of the current of injury-including total intracardiac EGM duration, maximum ST elevation, and maximum ST elevation 80 msec after the first EGM deflection-will be assessed immediately after helix deployment, as the current of injury is a dynamic and time-dependent electrical phenomenon.

Following implantation-after device connection and prior to discharge-and throughout the follow-up period, electrical parameters (sensing, impedance, and capture threshold) will be assessed using the device programmer provided by the manufacturer of the implanted device.

Follow-up visits are scheduled at 1 and 12 months post-implantation and may be conducted either as in-person ambulatory visits or via remote monitoring, according to the standard clinical practice of each center. During these visits, lead dislodgement and any significant variations in electrical parameters will also be assessed. The total follow-up duration is 12 months from implantation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy.
* Age under 18 years.
* Implantation of a subcutaneous ICD (S-ICD).
* Implantation of a leadless pacemaker.
* Patients requiring a new lead position with a previously implanted pacemaker or ICD

Primary outcomes:
measure: Slew rate value of active fixation leads (pacing or defibrillator leads) measured at the time of implantation
timeFrame: After the enrollment, at the time of implantation, prior to helix deployment for active lead fixation
Secondary outcomes:
measure: Current of injury of active fixation leads (pacing or defibrillator leads) measured at the time of implantation
timeFrame: After the enrollment, at the time of implantation, immediately following helix deployment for active lead fixation
measure: Sensing of active fixation leads (pacing or defibrillator leads)
timeFrame: From enrollment at the time of implantation to the end of follow-up at 12 months
measure: Capture threshold of active fixation leads (pacing or defibrillator leads)
timeFrame: From enrollment at the time of implantation to the end of follow-up at 12 months
measure: Impedance of active fixation leads (pacing or defibrillator leads)
timeFrame: From enrollment at the time of implantation to the end of follow-up at 12 months
Other outcomes:
measure: Lead dislodgement
timeFrame: From the implantation to the end of follow-up at 12 months
measure: Significant variation in electrical parameters
timeFrame: From the implantation to the end of follow-up at 12 months
Locations:
city: Fidenza
country: Italy
facility: Azienda Unità Sanitaria Locale di Parma
Study officials:
affiliation: Cardiology Unit, Medical and Diagnostics Department, Fidenza Hospital, Azienda USL of Parma
name: Paolo Pastori, MD
role: PRINCIPAL_INVESTIGATOR
References: