Optimizing Left Ventricular Lead To Improve Cardiac Output

Congestive Heart Failure Clinical Trial

— CARE/VOLCANO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399801
• Other study ID #: F/N-R09-284IL
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: September 25, 2014

Study information

• Verified date: August 2022
• Source: Main Line Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 25, 2014
• Est. primary completion date: September 25, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Congestive Heart Failure
• Dilated Cardiomyopathy
• Heart Failure
• Ischemic Congestive Cardiomyopathy

Intervention

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
• standard implantation of the LV lead
Standard implantation of the LV lead with measurements of flow

Locations

Country	Name	City	State
United States	Lankenau Hosspital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Ann Marie Chikowski	Main Line Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Six months
Secondary	Change in End diastolic volume	End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.	Six months
Secondary	Change in ejection fraction	Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle	six months
Secondary	Increase in exercise capacity	Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output	six months
Secondary	Decrease in heart failure related hospital admissions	number of hospitalizations for CHF should decrease during follow up	six months