Clinical trial NCT01522755: Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Official title: Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradyarrhythmia
Keywords: Pacing lead
implant
pacemaker
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2012-02-01
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient implanted with 2 CapsureFix MRI pacing leads model 5086 in the atrium and in the ventricle

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ease of Implant
timeFrame: at implant
measure: Lead Stability
timeFrame: 3 months
measure: Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
timeFrame: 3 months
measure: Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
timeFrame: 3 months
measure: Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Regionnal d'Orléans La Source
Study officials:
affiliation: Centre Hospitalier Regionnal d'Orléans La Source
name: Olivier BIZEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: