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Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

NCT01576016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 950

Last updated 2020-11-10

Study results available
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Summary

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

Conditions

  • Adverse Effect of MRI on an Implanted Pacemaker Lead
  • Adverse Effect of MRI on an Implanted Pacemaker

Interventions

DEVICE

Accent MRI system (lead safety)

Patients implanted with an Accent MRI system

DEVICE

Accent MRI system (with MRI scan)

Patients implanted with an Accent MRI system will receive an MRI scan

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Grant Kim · Abbott Medical Devices

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-30
Primary Completion
2018-02-02
Completion
2018-02-02

Countries

  • United States
  • Australia
  • Belgium
  • Finland
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576016 on ClinicalTrials.gov