search
Back to results

Optimizing Left Ventricular Lead To Improve Cardiac Output (CARE/VOLCANO)

Primary Purpose

Ischemic Congestive Cardiomyopathy, Dilated Cardiomyopathy, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doppler flow measurement
standard implantation of the LV lead
Sponsored by
Ann Marie Chikowski
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Congestive Cardiomyopathy focused on measuring Cardiac Resynchronization Therapy, medically refractory heart failure patients

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lankenau Hosspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hemodynamicaly guided LV lead placement

Standard lead placement

Arm Description

optimized left ventricular lead placement

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in End diastolic volume
End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.
Change in ejection fraction
Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle
Increase in exercise capacity
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
number of hospitalizations for CHF should decrease during follow up

Full Information

First Posted
June 16, 2011
Last Updated
August 25, 2022
Sponsor
Ann Marie Chikowski
Collaborators
Main Line Health
search

1. Study Identification

Unique Protocol Identification Number
NCT01399801
Brief Title
Optimizing Left Ventricular Lead To Improve Cardiac Output
Acronym
CARE/VOLCANO
Official Title
Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 25, 2014 (Actual)
Study Completion Date
September 25, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ann Marie Chikowski
Collaborators
Main Line Health

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Congestive Cardiomyopathy, Dilated Cardiomyopathy, Congestive Heart Failure
Keywords
Cardiac Resynchronization Therapy, medically refractory heart failure patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hemodynamicaly guided LV lead placement
Arm Type
Experimental
Arm Description
optimized left ventricular lead placement
Arm Title
Standard lead placement
Arm Type
Active Comparator
Arm Description
Standard LV lead placement with no measurements to guide LV lead placement
Intervention Type
Procedure
Intervention Name(s)
Doppler flow measurement
Intervention Description
use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement
Intervention Type
Procedure
Intervention Name(s)
standard implantation of the LV lead
Intervention Description
Standard implantation of the LV lead with measurements of flow
Primary Outcome Measure Information:
Title
Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months
Description
Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Change in End diastolic volume
Description
End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.
Time Frame
Six months
Title
Change in ejection fraction
Description
Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle
Time Frame
six months
Title
Increase in exercise capacity
Description
Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output
Time Frame
six months
Title
Decrease in heart failure related hospital admissions
Description
number of hospitalizations for CHF should decrease during follow up
Time Frame
six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dusan Kocovic, MD
Organizational Affiliation
Lankenau Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lankenau Hosspital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Optimizing Left Ventricular Lead To Improve Cardiac Output

We'll reach out to this number within 24 hrs