Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
|ClinicalTrials.gov Identifier: NCT01522755|
Recruitment Status : Unknown
Verified July 2012 by Medtronic Bakken Research Center.
Recruitment status was: Recruiting
First Posted : February 1, 2012
Last Update Posted : July 27, 2012
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.
|Condition or disease||Intervention/treatment|
|Bradyarrhythmia||Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086|
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
Patients implanted with the CapsureFix MRI pacing lead
Patients implanted with the CapsureFix MRI pacing lead model 5086
Device: Pacing system implant with the CapsureFix MRI pacing lead model 5086
Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Predictive factors of a successful implant of the CapsureFix MRI lead model 5086 [ Time Frame: 3 months ]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.
- Ease of use of the CapsureFix pacing lead [ Time Frame: Up to 2 days after enrollment ]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 ]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 ]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 ]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 ]To describe the potential early adverse events occurring in the patient population implanted with the CapsureFix MRI lead model 5086
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522755
|Contact: Julie Ruizfirstname.lastname@example.org|
|Contact: Marc Mainardisemail@example.com|
|Centre Hospitalier Regionnal d'Orléans La Source||Recruiting|
|Orléans, France, 45067|
|Contact: Olivier BIZEAU, MD +33238229645 firstname.lastname@example.org|
|Principal Investigator:||Olivier BIZEAU, MD||Centre Hospitalier Regionnal d'Orléans La Source|