PRoMOTE Follow-up Observational Study
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT03009175
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
The purpose of the study is:
* To evaluate the Heart Failure Risk Status (HFRS) feature performance.
* To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
Inclusion Criteria
Patients that meet all of following criteria could be included in the study:
- Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
- Inclusion in the Medtronic Carelink Network.
- Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.
Exclusion Criteria
- Patients under the age of 18 years.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission. 6 months
- Secondary Outcome Measures
Name Time Method