Actively Recruiting
Slew Rate As a Predictor for Optimal Lead Fixation
Led by Paolo Pastori, MD · Updated on 2025-02-24
516
Participants Needed
1
Research Sites
210 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
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.
CONDITIONS
Official 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
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
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Trial Site Locations
Total: 1 location
1
Azienda Unità Sanitaria Locale di Parma
Fidenza, Italy, 43036
Actively Recruiting
Research Team
P
Paolo Pastori, MD
CONTACT
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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