RecruitingNot ApplicableNCT04441203

Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes

Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (the SELFIe-HF Trial): Program


Sponsor

Montreal Heart Institute

Enrollment

150 participants

Start Date

May 4, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to decreased: hospital admissions for heart failure (HF), emergency department consultation and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a regular HFC, has low device-related complications and is cost-effective, in New York Heart Association (NYHA) class III and II (requiring diuretics) patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a virtual heart failure clinic — where patients monitor their own fluid levels at home using a remote sensor and check in digitally with their care team — can prevent hospital readmissions. **You may be eligible if...** - You are 18 or older - You have heart failure with significant symptoms (NYHA class III) - You were hospitalized for heart failure in the past year, OR visited the emergency room or urgent clinic for heart failure at least once **You may NOT be eligible if...** - You recently had a heart attack, stent procedure, or open-heart surgery - You are currently in the hospital for another serious condition - You are unable to manage home monitoring devices - You have kidney failure requiring dialysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardioMems

novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System


Locations(1)

Montreal Heart Institute

Montreal, Quebec, Canada

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NCT04441203


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