Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device

Systolic Heart Failure Clinical Trial

Official title:

Validation of a Robust Method for Kinematic Analysis of Ventricular Mechanical Dyssynchrony by Two Dimensional Echocardiography in Patients With Cardiac Resynchronization Devices for Chronic Systolic Heart Failure and Conduction System Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01127334
• Other study ID #: 2010-0069
• Status: Withdrawn
• Phase: N/A
• First received: May 19, 2010
• Last updated: April 2, 2012
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2010
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults age 18-110 years

2. Must have a CRT-D (A biventricular pacemaker with defibrillator)

3. Last optimization of their device (CRT-D) must not have been done in the past 3 months

4. Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)

Exclusion Criteria:

1. Less than 18 years of age or greater than 110 years old.

2. Does not have a CRT-D

3. Optimization of their device has occurred in the past 3 months

4. Not on optimal medical therapy for heart failure as listed in the inclusion criteria.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States,