Optimizing Left Ventricular Lead To Improve Cardiac Output

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Brief Title

Optimizing Left Ventricular Lead To Improve Cardiac Output

Official Title

Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire

Brief Summary

      The purpose of this study is to determine if optimal lead placement, guided by the largest
      improvement in aortic flow measured by Doppler will:

        1. Improve the way the heart's left ventricle functions

        2. Decrease the number of hospital admissions for heart failure related symptoms

        3. Reduces uncoordinated heart contractions

        4. Improve quality of life as measured by the Minnesota Living with Heart Failure
           Questionaire and NYHA Class assessed after six months
    

Detailed Description

      The hypothesis of this study determines if response to CRT therapy could be improved by
      optimizing LV lead position at the time of the left ventricular pacing lead implantation.
      This optimization (using a Doppler wire) would alter the left ventricular activation pattern
      and contraction mechanics. This increase in contractility may improve the likelihood of
      mid/long term response to therapy. This study will compare 6-month response to CRT (left
      ventricular ejection fraction, decrease in left ventricular end systolic and end diastolic
      dimensions and volumes) in heart failure patients.

      The secondary objective will be to:

        1. To determine if optimal lead placement, guided by the largest improvement in stroke
           volume, results in a greater 6-month improvement in clinical QOL and NYHA class.

        2. Acutely compare and/or correlate intra-operative A-V and V-V timing optimization via
           invasive pressure volume data to post-operative echo optimization of these same
           parameters.

        3. Acutely contrast changes in stroke volume during pacing from several different left
           ventricular lead locations.
    


Study Type

Interventional


Primary Outcome

Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months

Secondary Outcome

 Change in End diastolic volume

Condition

Ischemic Congestive Cardiomyopathy

Intervention

Doppler flow measurement

Study Arms / Comparison Groups

 hemodynamicaly guided LV lead placement
Description:  optimized left ventricular lead placement

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

40

Start Date

December 2010

Completion Date

June 2013

Primary Completion Date

December 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical indication for CRT-P or CRT-D

          -  QRS Duration>=120 MSEC

          -  Left Ventricular Ejection fraction<=35%

          -  NYHA Class III-IV

          -  History of Cardiomyopathy, least one month post MI, or at least six months old in case
             of non-ischemic cardiomyopathy

          -  At least 18 years of afe

        Exclusion Criteria:

          -  Previous implanted CRT-P/CRT-D

          -  woman who are pregnant

          -  Psychological or emotional problems
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Dusan Kocovic, MD, 610-649-6980, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01399801

Organization ID

F/N-R09-284IL


Responsible Party

Principal Investigator

Study Sponsor

Main Line Health


Study Sponsor

Dusan Kocovic, MD, Principal Investigator, Lankenau Hospital


Verification Date

July 2012