Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370526
Status:
TERMINATED
Last Update Posted:
2008-01-11
First Post:
2006-08-29
Brief Title:
HEAL-HF A Cardiac Resynchronization Therapy CRT Outcomes Study
Sponsor:
Stereotaxis
Organization:
Stereotaxis
Study Overview
Official Title:
HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The literature shows that approximately 40 of individuals who receive a cardiac resynchronization therapy CRT device for symptomatic congestive heart failure CHF do not have a clinical benefit from the device The HEAL-HF protocol will compare the outcomes of conventionally placed CRT devices with magnetically placed CRT devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular LV lead
Detailed Description:
Baseline information will be obtained including QoL 6-minute walk and echo measurements The patient will be randomized to receive a conventionally-placed LV lead or randomized to receive a magnetically-placed LV lead The magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing Patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in HF symptoms Adverse events will also be recorded during the follow-up period
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