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Model 4396 Left Ventricular (LV) Lead Study

NCT00853593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2019-02-18

Study results available
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Summary

This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Conditions

Interventions

DEVICE

Pacing Lead

implant and follow-up of study device

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Derek Exner, MD · Foothills Hospital (University of Calgary)

  • Daniel Gras, MD · Nouvelles Cliniques Nantaises

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-07-31
Completion
2010-08-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Denmark
  • France
  • Italy
  • Saudi Arabia

Study Locations

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Entities

Diseases

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 NCT00853593 on ClinicalTrials.gov