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OpenTrials
Completed

NCT Number: NCT01522755

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.

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Key information

Conditions

Bradyarrhythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Regionnal d'Orléans La Source

Orléans, 45067, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacing system implant with the CapsureFix MRI pacing lead model 5086

Device

Pacing system implant with the CapsureFix MRI pacing lead model 5086

Primary outcomes

  1. Ease of Implant

    Time frame: at 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.

  2. Lead Stability

    Time frame: 3 months

    Lead stability of the Capsure Fix as measured by number of dislodgments

  3. Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086

    Time frame: 3 months

    Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086

  4. Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086

    Time frame: 3 months

    Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086

  5. Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086

    Time frame: 3 months

    Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2012
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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