Slew Rate As a Predictor for Optimal Lead Fixation
Recruiting now
Conditions studied: Defibrillators, Implantable, Electrodes, Implanted, Pacemaker, Artificial, Predictive Value of Tests
In brief
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.
Key facts
- Study ID
- NCT06842940
- Run by
- Paolo Pastori, MD
- People needed
- 516
- Starts
- 2023-02-18
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2025-02-24
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Implantation of a transvenous pacemaker with active lead fixation.
- Implantation of a transvenous implantable cardioverter-defibrillator (ICD) with active lead fixation.
You may not qualify if…
- 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 is running
- Azienda Unità Sanitaria Locale di Parma — Fidenza, Italy (enrolling)
Full record on ClinicalTrials.gov
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