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Model 20066 Left Ventricular (LV) Lead Study

NCT01365234 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-10-12

No results posted yet for this study

Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).

Conditions

Interventions

DEVICE

Pacing Lead

Implant and follow up of Model 20066 lead

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Raymond Yee, MD · London Health Sciences Centre, London, Ontario, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada
  • Malaysia
  • Sweden

Study Locations

More Related Trials

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 NCT01365234 on ClinicalTrials.gov