MedTrace Logo

POsition of Leads in Advanced heaRt Failure: the POLAR Study

NCT01515761 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-01-24

No results posted yet for this study

Summary

The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.

Conditions

Interventions

PROCEDURE

Postero-lateral

A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization.

PROCEDURE

Antero-Lateral

A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Lexington VA Medical Center

    collaborator FED

  • Sergio Thal, M.D.

    lead FED

Principal Investigators

  • Sergio Thal, M.D. · Southern Arizona VA Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01515761 on ClinicalTrials.gov