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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Medtronic Bakken Research Center.
Recruitment status was  Recruiting
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
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 700
Study Start Date: May 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522755

Contacts
Contact: Julie Ruiz +33155381788 julie.ruiz@medtronic.com
Contact: Marc Mainardis +33155381725 marc.mainardis@medtronic.com

Locations
France
Centre Hospitalier Regionnal d'Orléans La Source Recruiting
Orléans, France, 45067
Contact: Olivier BIZEAU, MD    +33238229645    olivier.bizeau@chr-orleans.fr   
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Olivier BIZEAU, MD Centre Hospitalier Regionnal d'Orléans La Source
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01522755     History of Changes
Other Study ID Numbers: 11
Study First Received: January 11, 2012
Last Updated: July 26, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés
France: Conseil National de l'Ordre des Médecins

Keywords provided by Medtronic Bakken Research Center:
Pacing lead
implant
pacemaker

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014