Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870281
Status:
TERMINATED
Last Update Posted:
2022-01-28
First Post:
2021-04-26
Brief Title:
Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIKs CRT-DX System
Sponsor:
Biotronik Inc
Organization:
Biotronik Inc
Study Overview
Official Title:
BIO-AffectDX Clinical Study
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study terminated due to significant delays in site start-up activities and enrollment in the setting of the ongoing COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIO-AffectDX
Brief Summary:
The purpose of the BIO-AffectDX Study is to prospectively evaluate improvement from baseline in heart failure subjects with atrial fibrillation AF implanted with a two-lead CRT-DX system with emphasis on a comparison of patient outcomes between AF subtypes
Detailed Description:
There is a need for more evidence about the benefits of Cardiac Resynchronization Therapy CRT in a patient population with heart failure and atrial fibrillation The BIO-AffectDX Study will gather information about adults with heart failure and atrial fibrillation who are treated with a CRT-DX device from many locations across the United States The BIO-AffectDX Study will look at the results of treatment in participants with the primary goal to evaluate the improvement in overall health prior to device implant through 12 months Overall health will be measured by your study doctor for AF improvement physical fitness and general quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None