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 status
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Subject meets the general indications for an implantable cardioverter defibrillator (ICD) with LV systolic function ≤ 35% as defined by echocardiography.

• Subject has moderate or severe heart failure, defined as NYHA Class III-IV for at least 90 days prior to enrollment.

• Subject has optimal pharmacological heart failure therapy for at least 30 days prior to enrollment.

• Subject has a 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm and PR interval < 320 ms measured from any two leads.

• 12 lead ECG with left bundle brunch block morphology and a QRS duration of at least 120 msec.

• Subject has creatinine < 2.5 mg/dL obtained no more than 30 days prior to enrollment.

• Subject has left ventricular ejection fraction < 35% by echocardiogram no more than 1 year prior to enrollment.

• Subject is willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation.

• Subject has a life expectancy of more than 180 days, per physician discretion.

• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law.

Locations
United States
Arizona
Southern Arizona VA Health Care System
Recruiting
Tucson
Kentucky
Lexington VA Medical Center
Recruiting
Lexington
Contact Information
Primary
Sergio Thal, M.D.
sergio.thal@va.gov
520-792-1450
Backup
Elizabeth Juneman, M.D.
elizabeth.juneman@va.gov
520-792-1450
Time Frame
Start Date: September 2010
Completion Date: March 2013
Participants
Target number of participants: 60
Treatments
Active Comparator: Postero-lateral
Left ventricular lateral wall lead position
Active Comparator: Antero-lateral
Left ventricular lateral wall lead position
Related Therapeutic Areas
Sponsors
Collaborators: Lexington VA Medical Center, Medtronic
Leads: Sergio Thal, M.D.

This content was sourced from clinicaltrials.gov

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