POsition of Leads in Advanced heaRt Failure: the POLAR Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Southern Arizona VA Health Care System.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Medtronic
Lexington VA Medical Center
Information provided by (Responsible Party):
Sergio Thal, M.D., Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier:
NCT01515761
First received: January 12, 2012
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Cardiac Resynchronization Therapy
Heart Failure
Procedure: Postero-lateral
Procedure: Antero-Lateral

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

Resource links provided by NLM:


Further study details as provided by Southern Arizona VA Health Care System:

Primary Outcome Measures:
  • Change (reduction) in left ventricular end systolic volume (LVESV) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in 6 minute walk tests [ Time Frame: 6 weeks, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial performance as measured by myocardial performance index (MPI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Papillary muscle velocity as determined by tissue doppler [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression of mitral regurgitation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area

  • Minnesota living heart failure survey [ Time Frame: 6 weeks, 3 and 6 months ] [ Designated as safety issue: No ]
  • Chronic heart failure hospitalizations [ Time Frame: Monitored during study participation ~ 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515761

Contacts
Contact: Sergio Thal, M.D. 520-792-1450 ext 4624 sergio.thal@va.gov
Contact: Elizabeth Juneman, M.D. 520-792-1450 ext 4624 elizabeth.juneman@va.gov

Locations
United States, Arizona
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Sergio Thal, M.D.    520-792-1450 ext 4624    sergio.thal@va.gov   
Contact: Elizabeth Juneman, M.D.    520-792-1450 ext 4624    elizabeth.juneman@va.gov   
Principal Investigator: Sergio Thal, M.D.         
Sub-Investigator: Elizabeth Juneman, M.D.         
Sub-Investigator: Hoang Thai, M.D.         
United States, Kentucky
Lexington VA Medical Center Recruiting
Lexington, Kentucky, United States, 40502
Contact: Samy Elayi, M.D.    859-233-4511      
Principal Investigator: Samy Elayi, M.D.         
Sponsors and Collaborators
Sergio Thal, M.D.
Medtronic
Lexington VA Medical Center
Investigators
Principal Investigator: Sergio Thal, M.D. Southern Arizona VA Health Care System
  More Information

No publications provided

Responsible Party: Sergio Thal, M.D., Electrophyisology Laboratory Director, Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier: NCT01515761     History of Changes
Other Study ID Numbers: PIIT1A
Study First Received: January 12, 2012
Last Updated: January 23, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on September 14, 2014