RecruitingNot Applicable

Slew Rate As a Predictor for Optimal Lead Fixation

Italy516 participantsStarted 2023-02-18

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06842940

SponsorPaolo Pastori, MD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-28

Contact for this trial

Paolo Pastori, MD

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

View on ClinicalTrials.gov More Defibrillators, Implantable trials