Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158015
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2005-09-08
Brief Title:
Prospective Minnesota Study of ECHO Tissue Doppler Imaging in Cardiac Resynchronization Therapy
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Hennepin Healthcare Research Institute
Study Overview
Official Title:
Prospective Minnesota Study of ECHO Tissue Doppler Imaging in Cardiac Resynchronization Therapy
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess whether tissue doppler imaging is useful in predicting which patients will respond most to Cardiac Resynchronization therapy a type of pacemaker
Detailed Description:
Cardiac Resynchronization Therapy CRT is a newly developed therapy designed to improve outcomes in patients with heart failureHF Recent studies have shown significant symptomatic improvement and a decrease in hospitalization and mortality with CRT However up to 30 of patients do not experience improvement with this invasive and costly therapy Tissue Doppler Imaging TDI is emerging as an effective tool for non-invasively assessing mechanical dyssynchrony of the left ventricle LV and may aid in the identification of LV mechanical dyssynchrony to predict clinical response to CRT PROMISE-CRT is designed to address the following hypothesis Changes in tissue doppler imaging measures of left ventricular mechanical dyssynchrony from baseline to one week following cardiac resynchronization therapy will correlate with the clinical response at three months Seventy HF patients clinically indicated to receive CRT will be enrolled in this six-month multi-center study conducted in the Minneapolis-St Paul metropolitan area TDI analyses measures of clinical improvement and LV remodeling will be conducted one week three months six months after CRT implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None