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

Bradyarrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522755
• Other study ID #: 11
• Status: Completed
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2020
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Regionnal d'Orléans La Source	Orléans

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of Implant	Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.	at implant
Primary	Lead Stability	Lead stability of the Capsure Fix as measured by number of dislodgments	3 months
Primary	Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086	Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086	3 months
Primary	Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086	Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086	3 months
Primary	Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086	Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086	3 months