Recruiting

Observational StudyPOsition of Leads in Advanced heaRt Failure: the POLAR Study

Sponsor:

Sergio Thal, M.D.

Code:

NCT01515761

Conditions

Cardiac Resynchronization Therapy

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Postero-lateral

Antero-Lateral

Study Details

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.

Conditions

Cardiac Resynchronization Therapy

Heart Failure

Study ID

NCT01515761

Start date

Sep, 2010

Status verified date

Jan, 2012

Primary completion date

Mar, 2013

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Postero-lateral

Left ventricular lateral wall lead position

active comparator: Antero-lateral

Left ventricular lateral wall lead position

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sergio Thal, M.D.

520-792-1450 sergio.thal@va.gov

Elizabeth Juneman, M.D.

520-792-1450 elizabeth.juneman@va.gov

Locations

Southern Arizona VA Health Care System

Recruiting

Tucson, Arizona, United States, 85723

Contacts

Sergio Thal, M.D.

520-792-1450 sergio.thal@va.gov

Elizabeth Juneman, M.D.

520-792-1450 elizabeth.juneman@va.gov

Principal Investigator:

Sergio Thal, M.D.

Lexington VA Medical Center

Recruiting

Lexington, Kentucky, United States, 40502

Contacts

Samy Elayi, M.D.

859-233-4511

Principal Investigator:

Samy Elayi, M.D.

More Information

Sponsor

Sergio Thal, M.D.

Last update posted

Jan 24, 2012

Last verified

Jan, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sergio Thal, M.D. on 2012-01-24.