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RECRUITING
NCT06842940

Slew Rate As a Predictor for Optimal Lead Fixation

Sponsor: Paolo Pastori, MD

View on ClinicalTrials.gov

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.

Official title: Evaluating Slew Rate As a Predictor for Optimal Lead Fixation in Transvenous Cardiac Implantable Devices: a Prospective Multicenter Study

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

516

Start Date

2023-02-18

Completion Date

2027-02-28

Last Updated

2025-02-24

Healthy Volunteers

No

Locations (1)

Azienda Unità Sanitaria Locale di Parma

Fidenza, Italy