Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system. Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances. These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history). Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086. This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.
Study Type
OBSERVATIONAL
Enrollment
409
Pacing system implant with the CapsureFix MRI pacing lead model 5086
Centre Hospitalier Regionnal d'Orléans La Source
Orléans, France
Ease of Implant
Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.
Time frame: at implant
Lead Stability
Lead stability of the Capsure Fix as measured by number of dislodgments
Time frame: 3 months
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086
Time frame: 3 months
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Time frame: 3 months
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Time frame: 3 months
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