CARE/VOLCANO: Optimizing Left Ventricular Lead To Improve Cardiac Output

Sponsor

Main Line Health (Other)

Overall Status

Unknown status

CT.gov ID

NCT01399801

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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:

Improve the way the heart's left ventricle functions
Decrease the number of hospital admissions for heart failure related symptoms
Reduces uncoordinated heart contractions
Improve quality of life as measured by the Minnesota Living with Heart Failure Questionaire and NYHA Class assessed after six months

Condition or Disease	Intervention/Treatment	Phase
Ischemic Congestive Cardiomyopathy Dilated Cardiomyopathy Congestive Heart Failure	Procedure: Doppler flow measurement Procedure: standard implantation of the LV lead	N/A

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hemodynamicaly guided LV lead placement optimized left ventricular lead placement	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
Active Comparator: Standard lead placement Standard LV lead placement with no measurements to guide LV lead placement	Procedure: standard implantation of the LV lead Standard implantation of the LV lead with measurements of flow

Arm

Intervention/Treatment

Experimental: hemodynamicaly guided LV lead placement

optimized left ventricular lead placement

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

Active Comparator: Standard lead placement

Standard LV lead placement with no measurements to guide LV lead placement

Procedure: standard implantation of the LV lead

Standard implantation of the LV lead with measurements of flow

Outcome Measures

Primary Outcome Measures

Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months [Six months]
Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lankenau Hosspital	Wynnewood	Pennsylvania	United States	19096

Sponsors and Collaborators

Main Line Health

Investigators

Principal Investigator: Dusan Kocovic, MD, Lankenau Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dusan Kocovic, M.D.,, Dusan Kocovic, MD, Main Line Health

ClinicalTrials.gov Identifier:

NCT01399801

Other Study ID Numbers:

F/N-R09-284IL

First Posted:

Jul 22, 2011

Last Update Posted:

Jul 18, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Dusan Kocovic, M.D.,, Dusan Kocovic, MD, Main Line Health

Cardiac Resynchronization Therapy

medically refractory heart failure patients

Additional relevant MeSH terms:

Heart Failure

Cardiomyopathies

Cardiomyopathy, Dilated

Study Results

No Results Posted as of Jul 18, 2012