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EMRI SureScan™ Clinical Study

NCT00433654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2025-09-15

Study results available
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Summary

The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

Conditions

  • Bradycardia
  • Slow Heart Beat

Interventions

DEVICE

Implantable Pulse Generator (IPG) and Pacing Leads (wires)

Pacer and leads

OTHER

Magnetic Resonance Imaging (MRI) scan

One hour MRI scan on the head and lower back.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • EMRI SureScan Clinical Study Team · Medtronic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-11-30
Completion
2010-08-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Switzerland
  • United Kingdom

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 NCT00433654 on ClinicalTrials.gov