Clinical Trial: INGEVITY™ Observational Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: INGEVITY™ Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (MRI) Usage With a New Lead for Bradycardia Pacing

Brief Summary:

The objectives of this registry are to

  1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events
  2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts.
  3. Collect physician feedback on lead handling with the INGEVITY lead

in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.


Detailed Summary:
Sponsor: Boston Scientific Corporation

Current Primary Outcome: Number of patients with a Serious Adverse Device Effect during the first 3 months post implant [ Time Frame: 91 calendar days post-implant ]

Implant Procedure is Day 0 all future follow timelines are based on this date.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with a specific Serious Adverse Device Effect types during the first 3 months post implant [ Time Frame: 91 calendar days post implant ]
    Implant Procedure is Day 0 all future follow timelines are based on this date.
  • Number of patients with MRI procedure performed as a measure of the real-world frequency of MRI procedures in a pacemaker population including collection of information on scanned body parts [ Time Frame: 365 calendar days post implant ]
    Implant Procedure is Day 0 all future follow timelines are based on this date.
  • Physician implant handling survey scores as a measure of physician satisfaction [ Time Frame: Day 0 as defined in CIP ]
    The purpose of this additional, observational endpoint is to evaluate the physician satisfaction with the lead handling after each implant. Implant Procedure is Day 0 all future follow timelines are based on this date.


Original Secondary Outcome: Same as current

Information By: Boston Scientific Corporation

Dates:
Date Received: April 11, 2014
Date Started: April 2014
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017