Using slew rate to predict lead performance in pacemakers and defibrillators
Evaluating Slew Rate As a Predictor for Optimal Lead Fixation in Transvenous Cardiac Implantable Devices: a Prospective Multicenter Study
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 |
|---|---|
| Enrollment | 516 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Azienda Unità Sanitaria Locale di Parma Academic / other |
| Locations | 1 site (Fidenza) |
| Trial ID | NCT06842940 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing implantation of a transvenous pacemaker or ICD with active lead fixation.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Fidenza
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.