A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony

Heart Failure Clinical Trial

Official title:

A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony: Hemodynamic Assessment by 4D Segmental Ejection Fraction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01007981
• Other study ID #: 1124400
• Status: Withdrawn
• Phase: N/A
• First received: November 4, 2009
• Last updated: October 3, 2016
• Start date: November 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices.

Description:

Cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (LV) conduction delay and contraction dyssynchrony. It can improve quality of life and results in better survival in this selected group of patients. However, patients have different responses to CRT, and up to 30% of those implanted show no response at all. Ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to CRT and to measure ventricular dyssynchrony. Despite this, no single echo criterion to date can predict successful CRT over current guidelines.

In this study, we propose to compare LV muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4D segmental ejection fraction (EF), a novel modality brought recently by University of Missouri Echocardiography laboratory.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years.

Exclusion Criteria:

• Acute decompensated congestive heart failure.

• chronic permanent atrial fibrillation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4D echo is the best modality to measure systolic dyssynchrony index		Two years	No