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

This study is currently recruiting participants.
Verified July 2012 by Medtronic Bakken Research Center
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01522755
First received: January 11, 2012
Last updated: July 26, 2012
Last verified: July 2012

January 11, 2012
July 26, 2012
May 2011
August 2013   (final data collection date for primary outcome measure)
Predictive factors of a successful implant of the CapsureFix MRI lead model 5086 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To define the predictive factors of a successful implant of the CapsureFix MRI lead model 5086 Influence of the following factors will be assesssed: physician experience parameters (i.e. number of annual implants, years of pacing experience, annual number of tined and screw-in atrial and ventricular leads implanted), handling characteristics score, fluoroscopy and implant time, vein approach, implant sites and patient history.
Same as current
Complete list of historical versions of study NCT01522755 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Predictive Factors of a Successful Implant of the CapsureFix MRI 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Bradyarrhythmia
Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086
Pacing system implant with the CapsureFix MRI pacing lead model 5086
Patients implanted with the CapsureFix MRI pacing lead
Patients implanted with the CapsureFix MRI pacing lead model 5086
Intervention: Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Julie Ruiz +33155381788 julie.ruiz@medtronic.com
Contact: Marc Mainardis +33155381725 marc.mainardis@medtronic.com
France
 
NCT01522755
11
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Principal Investigator: Olivier BIZEAU, MD Centre Hospitalier Regionnal d'Orléans La Source
Medtronic Bakken Research Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP