Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01045291
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2010-01-08
Brief Title:
Pacing for Heart Failure With Preserved Ejection Fraction
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Pacing for Heart Failure With Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2013-05
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:
HFpEF
Brief Summary:
The purpose of this research study is to evaluate the safety of a new pacing method Fusion Pacing for heart failure patients with an ejection fraction EF greater than 50 over a period of 4 months and determine the effects on different measures of heart failure This new pacing method may allow the heart to pump more efficiently Participation in this study will last approximately 8 months
Detailed Description:
Patients with an EF greater than 50 and a regional mechanical delay of 65ms an indication of mechanical dyssynchrony will receive an implantable cardioverter defibrillator ICD with a special pacing feature When the feature is active the device wil pace the left ventricle to target improved pump efficiency Patients will have the feature active for 4 months and inactive for 4 months The order will be randomized and the patient will not know whether the pacing is active or not Echocardiography biomarkers exercise testing quality of life QOL testing and device information will be used to compare the patients status while the feature is active vs inactive
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