CardioMEMS Monitoring for Heart Failure
(SELFIe-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a small device that monitors heart pressure and sends data to doctors remotely. It targets heart failure patients who have had hospitalizations. The goal is to see if this remote monitoring can reduce hospital visits and improve patient outcomes. A recently approved implantable wireless monitor has been shown to be effective in reducing hospitalizations among heart failure patients.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should be on diuretics, so you may need to continue those if you are already taking them.
Is the CardioMEMS HF System safe for use in humans?
How is the CardioMEMS treatment different from other heart failure treatments?
The CardioMEMS HF System is unique because it is an implantable device that wirelessly monitors pulmonary artery pressure, allowing for remote management of heart failure. This proactive approach helps reduce hospitalizations by alerting healthcare providers to changes in pressure before symptoms worsen, unlike traditional treatments that often react to symptoms after they appear.12346
What data supports the effectiveness of the CardioMEMS HF System treatment for heart failure?
Who Is on the Research Team?
Anique Ducharme
Principal Investigator
Montreal Heart Institute
Jean Rouleau, MD
Principal Investigator
Montreal Heart Institute
Are You a Good Fit for This Trial?
Adults over 18 with chronic heart failure, able to use a smartphone or iPad for self-management. They must have had a recent hospital visit for heart failure and meet specific criteria like PA branch diameter and NT-proBNP levels. Excluded are those with recent major cardiovascular events, severe conditions, certain medication intolerances, or who are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CardioMems
CardioMems is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montreal Heart Institute
Lead Sponsor