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

• Ease of use of the CapsureFix pacing lead [ Time Frame: Up to 2 days after enrollment ] [ Designated as safety issue: No ]
  A handling score based on answers to a qualitative questionnaire will be used to evaluate the ease of use of the CapsureFix and compare it with previously available model for which the same score was used.
• Electrical performances of the CapsureFix [ Time Frame: Up to 7 days after enrollment ] [ Designated as safety issue: No ]
  Mean values of pacing thresholds, pacing impedances and sensed signal amplitudes will be used to evaluate the electrical performances of the CapsureFix pacing lead and compare them with that of previously available models
• Slew rate of the CapsureFix MRI lead model 5086 [ Time Frame: Up to 2 days after enrollment ] [ Designated as safety issue: No ]
  To evaluate the slew rate of the CapsureFix MRI lead model 5086
• Description of the population implanted with an MRI conditionally safe pacing system [ Time Frame: Up to 2 days after enrollment ] [ Designated as safety issue: No ]
  To describe the population implanted with an MRI conditionaly safe pacing system (i.e. proportion of patients with an history of MRI exams, proportion of patients with planned MRI exams, proportion of patients for which the investigator estimated the patient may need a MRI exam in the future)
• Description of potential early adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  To describe the potential early adverse events occurring in the patient population implanted with the CapsureFix MRI lead model 5086

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.

Patient implanted with 2 CapsureFix MRI pacing leads model 5086 in the atrium and in the ventricle

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