Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04506684
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2020-08-06
Brief Title:
Reveal LINQ Respiration Clinical Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Reveal LINQ Respiration Clinical Study
Status:
COMPLETED
Status Verified Date:
2022-10
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:
The LINQ Respiration study will collect and characterize Reveal LINQ derived respiration data from patients undergoing a simulated 24-hour time period while being monitored with capnography
Detailed Description:
The Reveal LINQ Respiration study is a Non-Significant Risk IDE observational non-randomized multi-center clinical study The study is expected to be conducted at up to 5 centers in the United States and up to 100 subjects will be enrolled with no more than 25 subjects enrolled per site In addition a minimum of 30 of all enrolled subjects will have a history of heart failure
All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware downloaded onto their implanted Reveal LINQ device Holter monitor and capnography monitor applied and undergo a series of activity and breathing maneuvers The expected duration of subject participation in the study from start of study procedures to study exit is approximately 15 hours The expected total study duration from time of first enrollment to the exit of last enrolled subject is approximately 3 months
All Adverse events will be collected throughout the study duration of a subjects participation in the study beginning at the time of informed consent
All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware downloaded onto their implanted Reveal LINQ device Holter monitor and capnography monitor applied and undergo a series of activity and breathing maneuvers The expected duration of subject participation in the study from start of study procedures to study exit is approximately 15 hours The expected total study duration from time of first enrollment to the exit of last enrolled subject is approximately 3 months
All Adverse events will be collected throughout the study duration of a subjects participation in the study beginning at the time of informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None