Ignite Creation Date:
2024-05-05 @ 10:55 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01216670
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2010-04-21
Brief Title:
Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure
Sponsor:
Medtronic Italia
Organization:
Medtronic Italia
Study Overview
Official Title:
Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure
Status:
COMPLETED
Status Verified Date:
2013-02
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:
CARRYINGON
Brief Summary:
The CARRYING ON for heart failure HF study is a national prospective post market interventional multi-center open-label pilot trialThe purpose of the study is to assess a short term and a long term period incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction EF that are hospitalized for acute cardiac decompensation
Detailed Description:
The CARRYING ON for heart failure HF study is a national prospective post market interventional multi-center open-label pilot trial designed in two phases
The purpose of the study is to assess a short term 6 months follow-up - Phase 1 and a long term period 24 months follow-up - Phase 2 incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction EF that are hospitalized for acute cardiac decompensation A previously implanted Reveal XT device will be used to collect heart rhythm information
The purpose of the study is to assess a short term 6 months follow-up - Phase 1 and a long term period 24 months follow-up - Phase 2 incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction EF that are hospitalized for acute cardiac decompensation A previously implanted Reveal XT device will be used to collect heart rhythm information
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