NCT01399801

Optimizing Left Ventricular Lead To Improve Cardiac Output

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ann Marie Chikowski · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Congestive Cardiomyopathy
• Dilated Cardiomyopathy
• Congestive Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Doppler flow measurement	use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement
PROCEDURE	standard implantation of the LV lead	Standard implantation of the LV lead with measurements of flow

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-09-25
• Completion: 2014-09-25
• First posted: 2011-07-22
• Last updated: 2022-08-30

Locations

1 site across 1 country: United States