Using slew rate to predict lead performance in pacemakers and defibrillators
Official title: Evaluating Slew Rate As a Predictor for Optimal Lead Fixation in Transvenous Cardiac Implantable Devices: a Prospective Multicenter Study
Run by Azienda Unità Sanitaria Locale di Parma · NCT06842940 · Data updated 2026-11-12
This study is testing if measuring the electrical signals during the placement of pacemakers and defibrillators can help predict how well the devices will work over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 516 (estimated) |
| Sponsor | Azienda Unità Sanitaria Locale di Parma Academic / other |
| Locations | 1 site (Fidenza) |
| Status | Recruiting |
| Started | February 18, 2023 |
| Main results expected | February 28, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | February 24, 2025 |
| Trial ID | NCT06842940 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients undergoing implantation of a transvenous pacemaker or ICD with active lead fixation.
✕Probably not a fit
Patients who are pregnant, under 18 years old, or those requiring a new lead position with a previously implanted device may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify reliable electrical parameters measured during the implantation of transvenous pacemakers and implantable cardioverter-defibrillators (ICDs) that can predict optimal lead fixation and long-term performance. It focuses on the correlation between slew rate and other electrical parameters at the time of implantation and their relationship with device performance at a 12-month follow-up. Participants will undergo regular evaluations, including device interrogations at 1 and 12 months post-implantation, as part of routine clinical care. The study seeks to establish whether slew rate can serve as a predictor of long-term lead stability.
Why it matters
Potential benefit: If successful, this study could enhance the reliability of lead fixation in pacemakers and ICDs, potentially improving patient outcomes and device longevity.
How similar studies have gone: While the significance of slew rate in predicting long-term lead stability has been poorly studied, this approach may provide novel insights into lead performance.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Azienda Unità Sanitaria Locale di Parma
Fidenza, Italy Recruiting
Study contacts
- Principal investigator: Paolo Pastori, MD — Cardiology Unit, Medical and Diagnostics Department, Fidenza Hospital, Azienda USL of Parma
- Study coordinator: Paolo Pastori, MD
- Email: ppastori@ausl.pr.it
- Phone: +39-524-515233
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.