POsition of Leads in Advanced heaRt Failure: the POLAR Study (POLAR)

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Intervention / Treatment: Procedure: Postero-lateral; Procedure: Antero-Lateral

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Thal, M.D.; Phone Number: 4624 520-792-1450; Email: sergio.thal@va.gov
• Study Contact Backup: Name: Elizabeth Juneman, M.D.; Phone Number: 4624 520-792-1450; Email: elizabeth.juneman@va.gov

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85723
      • Recruiting
      • Southern Arizona VA Health Care System
      • Contact: Sergio Thal, M.D.; Phone Number: 4624 520-792-1450; Email: sergio.thal@va.gov
      • Contact: Elizabeth Juneman, M.D.; Phone Number: 4624 520-792-1450; Email: elizabeth.juneman@va.gov
      • Principal Investigator: Sergio Thal, M.D.
      • Sub-Investigator: Elizabeth Juneman, M.D.
      • Sub-Investigator: Hoang Thai, M.D.
  • Kentucky
    • Lexington, Kentucky, United States, 40502
      • Recruiting
      • Lexington VA Medical Center
      • Contact: Samy Elayi, M.D.; Phone Number: 859-233-4511
      • Principal Investigator: Samy Elayi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subject has right bundle branch block morphology on a 12-lead ECG obtained no more than 90 days prior to enrollment.
• Subject had previous cardiac resynchronization therapy, a previous coronary venous lead, or meets the general indications for anti-bradycardia pacing defined as ventricular pacing > 40% by pacemaker interrogation.
• Subject has a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking.
• Subject has an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 30 days prior to enrollment.
• Subject currently requires dialysis.
• Subject has severe chronic obstructive pulmonary disease (COPD), defined as FEV1/FVC < 60%, or as defined by a physician.
• Subject has had a myocardial infarction within 30 days prior to enrollment or coronary artery disease (CAD) in which surgical or percutaneous correction was performed within 30 days prior to enrollment.
• Subject has hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
• Subject is on IV inotropic agents.
• Subject has any mitral valve prosthesis, or a mechanical aortic or tricuspid prosthesis
• Subject is enrolled in any concurrent study, without Medtronic written approval, which may confound the results of this study.
• Subject is pregnant or planning to get pregnant.
• Subject requires oxygen for medical reasons other than CHF.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Postero-lateral; Left ventricular lateral wall lead position	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.
Active Comparator: Antero-lateral; Left ventricular lateral wall lead position	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change (reduction) in left ventricular end systolic volume (LVESV)	3 and 6 months
Change in 6 minute walk tests	6 weeks, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial performance as measured by myocardial performance index (MPI)		6 months
Papillary muscle velocity as determined by tissue doppler		6 months
Progression of mitral regurgitation	as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area	6 months
Minnesota living heart failure survey		6 weeks, 3 and 6 months
Chronic heart failure hospitalizations		Monitored during study participation ~ 6 months

Collaborators and Investigators

• Sponsor: Sergio Thal, M.D.
• Collaborators: Medtronic; Lexington VA Medical Center
• Investigators: Principal Investigator: Sergio Thal, M.D., Southern Arizona VA Health Care System

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 23, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Estimate): January 24, 2012
• Last Update Submitted That Met QC Criteria: January 23, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PIIT1A