Study Stopped
Principal Investigator terminated study
Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device
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
1 other identifier
observational
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedApril 4, 2012
May 1, 2010
1 year
May 19, 2010
April 2, 2012
Conditions
Keywords
Study Arms (1)
Systolic Heart Failure, Dyssynchrony, CRT-D
Patients with systolic heart failure and dyssynchrony that have a CRT-D that have not been optimized in the past 3 months.
Eligibility Criteria
Cardiology and electrophysiology clinics
You may qualify if:
- Adults age 18-110 years
- Must have a CRT-D (A biventricular pacemaker with defibrillator)
- Last optimization of their device (CRT-D) must not have been done in the past 3 months
- 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.)
You may not qualify if:
- Less than 18 years of age or greater than 110 years old.
- Does not have a CRT-D
- Optimization of their device has occurred in the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donny R. Stokes, M.D.
University of Mississippi Medical Center
- STUDY DIRECTOR
John P. Payne, M.D.
University of Mississippi Medical Center
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 20, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
April 4, 2012
Record last verified: 2010-05