Optimizing Left Ventricular Lead To Improve Cardiac Output

NCT ID: NCT01399801

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-09-25

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:

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

hemodynamicaly guided LV lead placement

optimized left ventricular lead placement

Group Type: EXPERIMENTAL

Doppler flow measurement

Intervention Type: PROCEDURE

use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement

Standard lead placement

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

Group Type: ACTIVE_COMPARATOR

standard implantation of the LV lead

Intervention Type: PROCEDURE

Standard implantation of the LV lead with measurements of flow

Interventions

Doppler flow measurement

use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement

Intervention Type: PROCEDURE

standard implantation of the LV lead

Standard implantation of the LV lead with measurements of flow

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Main Line Health

OTHER

Sponsor Role: collaborator

Ann Marie Chikowski

OTHER

Sponsor Role: lead

Responsible Party

Ann Marie Chikowski

Division Manager Cardiology Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dusan Kocovic, MD

Role: PRINCIPAL_INVESTIGATOR

Lankenau Hospital

Locations

Lankenau Hosspital

Wynnewood, Pennsylvania, United States

Countries

United States

Other Identifiers

F/N-R09-284IL

Identifier Type: -

Identifier Source: org_study_id