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

August 25, 2022 updated by: Ann Marie Chikowski

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Hosspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann Marie Chikowski

Collaborators

Main Line Health

Investigators

  • Principal Investigator: Dusan Kocovic, MD, Lankenau Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 25, 2014

Study Completion (Actual)

September 25, 2014

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F/N-R09-284IL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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