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

Medtronic

Status: Completed

Conditions: Bradyarrhythmia

Treatments: Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086

Study type: Observational

Funder types: Industry

Identifiers

NCT01522755

11

Details and patient eligibility

About

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.

Enrollment: 409 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

409 participants in 1 patient group

Patients implanted with the CapsureFix MRI pacing lead

Description:

Patients implanted with the CapsureFix MRI pacing lead model 5086

Treatment:

Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086