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

NCT01522755 | Completed Results

• 1 other identifier: 11
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bradyarrhythmia

Keywords

Pacing lead; implant; pacemaker

Outcome Measures

Primary Outcomes (5)

• 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

• Lead Stability

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

  3 months

• 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

• 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

• 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

Study Arms (1)

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

Interventions

Pacing system implant with the CapsureFix MRI pacing lead model 5086 DEVICE

Pacing system implant with the CapsureFix MRI pacing lead model 5086

Patients implanted with the CapsureFix MRI pacing lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (1)

Centre Hospitalier Regionnal d'Orléans La Source

Orléans, 45067, France

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Foudali Latifa
• Organization: Medtronic

latifa.foudali@medtronic.com

+33 631992144

Study Officials

• Olivier BIZEAU, MD

  Centre Hospitalier Regionnal d'Orléans La Source

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: February 1, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 2, 2025
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Locations

FR (1)