POsition of Leads in Advanced heaRt Failure: the POLAR Study

Heart Failure Clinical Trial

— POLAR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01515761
• Other study ID #: PIIT1A
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2012
• Last updated: January 23, 2012
• Start date: September 2010

Study information

• Verified date: January 2012
• Source: Southern Arizona VA Health Care System
• Contact: Sergio Thal, M.D.
• Phone: 520-792-1450
• Email: sergio.thal[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lexington VA Medical Center	Lexington	Kentucky
United States	Southern Arizona VA Health Care System	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Sergio Thal, M.D.	Lexington VA Medical Center, Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (reduction) in left ventricular end systolic volume (LVESV)		3 and 6 months	No
Primary	Change in 6 minute walk tests		6 weeks, 3 and 6 months	No
Secondary	Myocardial performance as measured by myocardial performance index (MPI)		6 months	No
Secondary	Papillary muscle velocity as determined by tissue doppler		6 months	No
Secondary	Progression of mitral regurgitation	as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area	6 months	No
Secondary	Minnesota living heart failure survey		6 weeks, 3 and 6 months	No
Secondary	Chronic heart failure hospitalizations		Monitored during study participation ~ 6 months	Yes