Optimizing Left Ventricular Lead To Improve Cardiac Output

NCT01399801 | Completed DMC

• 1 other identifier: F/N-R09-284IL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Congestive Cardiomyopathy; Dilated Cardiomyopathy; Congestive Heart Failure

Keywords

Cardiac Resynchronization Therapy; medically refractory heart failure patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in End diastolic volume

  Six months

• Change in ejection fraction

  six months

• Increase in exercise capacity

  six months

• Decrease in heart failure related hospital admissions

  six months

Study Arms (2)

hemodynamicaly guided LV lead placement

EXPERIMENTAL

optimized left ventricular lead placement

Procedure: Doppler flow measurement

Standard lead placement

ACTIVE COMPARATOR

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

Procedure: standard implantation of the LV lead

Interventions

Doppler flow measurement PROCEDURE

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

hemodynamicaly guided LV lead placement

standard implantation of the LV lead PROCEDURE

Standard implantation of the LV lead with measurements of flow

Standard lead placement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous implanted CRT-P/CRT-D
• woman who are pregnant
• Psychological or emotional problems

Sponsors & Collaborators

• Ann Marie Chikowski: lead
• Main Line Health: collaborator

Study Sites (1)

Lankenau Hosspital

Wynnewood, Pennsylvania, 19096, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dusan Kocovic, MD

  Lankenau Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Manager Cardiology Research

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: July 22, 2011
• Study Start: December 1, 2010
• Primary Completion: September 25, 2014
• Study Completion: September 25, 2014
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

US (1)