Optimizing Left Ventricular Lead To Improve Cardiac Output

Ann Marie Chikowski12 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ischemic Congestive Cardiomyopathy Dilated Cardiomyopathy Congestive Heart Failure

Interventions

Doppler flow measurementPROCEDURE

use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement

standard implantation of the LV leadPROCEDURE

Standard implantation of the LV lead with measurements of flow

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Lankenau Hosspital

Wynnewood, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.

Time frame: Six months

Secondary Outcomes

Change in End diastolic volume

End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.

Time frame: Six months

Change in ejection fraction

Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle

Time frame: six months

Increase in exercise capacity

Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output

Time frame: six months

Decrease in heart failure related hospital admissions

number of hospitalizations for CHF should decrease during follow up

Time frame: six months

Data from ClinicalTrials.gov

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