Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146861
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2005-09-02
Brief Title:
LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Limiting Chronotropic Incompetence for Pacemaker Recipients
Status:
COMPLETED
Status Verified Date:
2017-05
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:
None
Brief Summary:
This study will compare how two different sensors inside the pacemaker may affect patients quality of life
Detailed Description:
The LIFE Study will estimate the prevalence of CI among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer Changes in chronotropic response between CI patients randomized to either blended sensor or accelerometer will be compared A sub-study will evaluate changes in functional capacity between CI patients randomized to either blended sensor or accelerometer
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