Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-26 @ 9:51 AM
Study NCT ID:
NCT00146861
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2005-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients
Sponsor:
Boston Scientific Corporation
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: