Actively Recruiting
Evaluating Slew Rate As a Predictor for Optimal Lead Fixation in Transvenous Cardiac Implantable Devices: a Prospective Multicenter Study
Led by Paolo Pastori, MD · Updated on 2025-02-24
516
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Paolo Pastori, MD
Lead Sponsor
U
University Hospital of Ferrara
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating electrical measurements taken during the implantation of transvenous pacemakers and implantable cardioverter-defibrillators (ICDs) to find the best predictors of long-term lead performance. The study focuses on whether the slew rate and other electrical parameters measured at implantation correlate with device function at 12 months. The goal is to improve the selection of optimal pacing sites to prevent device problems over time. This is a prospective observational study involving patients receiving active fixation leads for pacemakers or ICDs. Electrical parameters like slew rate, current of injury, sensing, impedance, and capture threshold will be measured before and after lead fixation using a consistent pacing system analyzer. Follow-up visits occur at 1 and 12 months after implantation, with assessments done in-person or via remote monitoring according to standard care. Participants will have their device's electrical parameters checked regularly, including sensing, impedance, and capture threshold, from implantation through the 12-month follow-up. Lead dislodgement and any significant changes in electrical measurements will also be monitored. The main outcome is the slew rate value measured at implantation prior to helix deployment, with secondary outcomes including current of injury and ongoing electrical performance over time.
CONDITIONS
Brief Title
Slew Rate As a Predictor for Optimal Lead Fixation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Implantation of a transvenous pacemaker with active lead fixation.
- Implantation of a transvenous implantable cardioverter-defibrillator (ICD) with active lead fixation.
- Age between 18 and 100 years.
- All genders are eligible.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants undergo implantation of transvenous pacemakers or implantable cardiac defibrillators with active lead fixation. Electrical parameters including slew rate, current of injury, sensing, impedance, and capture threshold are measured during implantation before and after helix deployment.
1 visit (in-person)
Duration - 12 months from implantation
Participants are monitored for lead performance through electrical parameter assessments and lead dislodgement checks during follow-up.
Visits at 1 month and 12 months post-implantation (in-person or remote monitoring)
Trial Site Locations
Total: 1 location
1
Azienda Unità Sanitaria Locale di Parma
Fidenza, Italy, 43036
Actively Recruiting
Research Team
P
Paolo Pastori, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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