NCT01515761

POsition of Leads in Advanced heaRt Failure: the POLAR Study

POsition of Leads in Advanced heaRt Failure: the POLAR Study - A 6 Month, Observational, Mult-centered, Blinded, Randomized Study to Determine if Lead Positioning in the Lateral Wall of LV in Patients Meeting Criteria for CRT Plays a Role in Determining Myocardial Function and Affect the Severity of Mitral Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sergio Thal, M.D. · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 6 month, multi-centered, blinded, randomized study. Approximately 60 patients will join this study. Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group.

Conditions

• Cardiac Resynchronization Therapy
• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-03-01
• First posted: 2012-01-24
• Last updated: 2012-01-24

Locations

2 sites across 1 country: United States