Slew Rate As a Predictor for Optimal Lead Fixation

NCT06842940 | Recruiting

• 1 other identifier: 920/2021/OSS/AUSLPR
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pacemaker; implantable cardiac defibrillator; lead; slew rate; sensing; active fixation; electrical performance

Outcome Measures

Primary Outcomes (1)

• 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.

  After the enrollment, at the time of implantation, prior to helix deployment for active lead fixation

Secondary Outcomes (4)

• Current of injury of active fixation leads (pacing or defibrillator leads) measured at the time of implantation

  After the enrollment, at the time of implantation, immediately following helix deployment for active lead fixation

• Sensing of active fixation leads (pacing or defibrillator leads)

  From enrollment at the time of implantation to the end of follow-up at 12 months

• Capture threshold of active fixation leads (pacing or defibrillator leads)

  From enrollment at the time of implantation to the end of follow-up at 12 months

• Impedance of active fixation leads (pacing or defibrillator leads)

  From enrollment at the time of implantation to the end of follow-up at 12 months

Other Outcomes (2)

• Lead dislodgement

  From the implantation to the end of follow-up at 12 months

• Significant variation in electrical parameters

  From the implantation to the end of follow-up at 12 months

Study Arms (1)

All patients

Patients undergoing a transvenous cardiac devices implant with active lead fixation (pacing or defibrillator leads)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paolo Pastori, MD: lead
• University Hospital of Ferrara: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator
• Azienda Unita Sanitaria Locale di Piacenza: collaborator

Study Sites (1)

Azienda Unità Sanitaria Locale di Parma

Fidenza, 43036, Italy

RECRUITING

Study Officials

• Paolo Pastori, MD

  Cardiology Unit, Medical and Diagnostics Department, Fidenza Hospital, Azienda USL of Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Pastori, MD

CONTACT

+39-524-515233; ppastori@ausl.pr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Paolo Pastori, MD

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 24, 2025
• Study Start: February 18, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)