POsition of Leads in Advanced heaRt Failure: the POLAR Study

NCT01515761 | Unknown DMC

• 1 other identifier: PIIT1A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

  6 months

• Minnesota living heart failure survey

  6 weeks, 3 and 6 months

• Chronic heart failure hospitalizations

  Monitored during study participation ~ 6 months

Study Arms (2)

Postero-lateral

ACTIVE COMPARATOR

Left ventricular lateral wall lead position

Procedure: Postero-lateral

Antero-lateral

ACTIVE COMPARATOR

Left ventricular lateral wall lead position

Procedure: Antero-Lateral

Interventions

Postero-lateral PROCEDURE

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.

Postero-lateral

Antero-Lateral PROCEDURE

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.

Antero-lateral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sergio Thal, M.D.: lead
• Medtronic: collaborator
• Lexington VA Medical Center: collaborator

Study Sites (2)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

RECRUITING

Lexington VA Medical Center

Lexington, Kentucky, 40502, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sergio Thal, M.D.

  Southern Arizona VA Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Thal, M.D.

CONTACT

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

Elizabeth Juneman, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Electrophyisology Laboratory Director

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 24, 2012
• Study Start: September 1, 2010
• Primary Completion: March 1, 2013
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

US (2)