PRoMOTE Follow-up Observational Study

Heart Failure Clinical Trial

— PRoMOTE FU  

Official title:

Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009175
• Other study ID #: PRoMOTE FU
• Status: Completed
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2016
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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