Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

Conditions
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Bradyarrhythmia

Intervention / Treatment
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* Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 18 Patient implanted with a fully automatic ICD and remotely followed-up, Patient geographically stable and able to attend FU at investigative site Patient who signed a data release authorization form, Exclusion Criteria: Patient whose mental or physical capacity impedes to give an informed data release authorization, Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study, Patients in New York Heart Association (NYHA) class IV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients implanted with the CapsureFix MRI pacing lead<br>Patients implanted with the CapsureFix MRI pacing lead model 5086 | Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086<br>* Pacing system implant with the CapsureFix MRI pacing lead model 5086<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at implant | 
| Lead Stability | Lead stability of the Capsure Fix as measured by number of dislodgments | 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 | 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 | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacing lead, implant, pacemaker