Clinical trial NCT01515761: POsition of Leads in Advanced heaRt Failure: the POLAR Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Resynchronization Therapy
Heart Failure
Lead sponsor: Southern Arizona VA Health Care System
Sponsor class: FED
Collaborators: name: Medtronic
name: Lexington VA Medical Center
First posted: 2012-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change (reduction) in left ventricular end systolic volume (LVESV)
timeFrame: 3 and 6 months
measure: Change in 6 minute walk tests
timeFrame: 6 weeks, 3 and 6 months
Secondary outcomes:
measure: Myocardial performance as measured by myocardial performance index (MPI)
timeFrame: 6 months
measure: Papillary muscle velocity as determined by tissue doppler
timeFrame: 6 months
measure: Progression of mitral regurgitation
timeFrame: 6 months
measure: Minnesota living heart failure survey
timeFrame: 6 weeks, 3 and 6 months
measure: Chronic heart failure hospitalizations
timeFrame: Monitored during study participation ~ 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Lexington
country: United States
facility: Lexington VA Medical Center
state: Kentucky
Study officials:
affiliation: Southern Arizona VA Health Care System
name: Sergio Thal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: