Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 6:49 PM
Study NCT ID:
NCT00757666
Status:
TERMINATED
Last Update Posted:
2017-06-14
First Post:
2008-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
APPROPRIATE - Rate Adaptive Pacing Sensor
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty enrollment; higher than planned patient attrition and data attrition
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPROPRIATE
Brief Summary:
The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: