Your session is about to expire
← Back to Search
Device
CardioMEMS Monitoring for Heart Failure (SELFIe-HF Trial)
N/A
Recruiting
Led By Anique Ducharme
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anatomical criteria: PA branch diameter between 7 mm - 15 mm, For BMI >35, distance from patient's back to target PA<10cm
Symptomatic HF (NYHA III) with recent heart failure admission in the previous year (12 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
SELFIe-HF Trial Summary
This trialshows that a virtual Heart Failure Clinic using PAP monitoring reduces hospital visits, emergency treatments, and deaths, is low-risk and cost-effective for NYHA class II & III patients.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing if managing heart failure through a virtual clinic using Pulmonary Artery Pressure monitoring leads to fewer hospital visits and better outcomes compared to standard care. It also evaluates the safety and cost-effectiveness of this approach in patients with different severities of heart failure.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from device implantation for PAP monitoring, possible infection risk at the site of implantation, allergic reactions to materials used in devices or medications prescribed during the trial.
SELFIe-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pulmonary artery size and my body structure meet the specific requirements.
Select...
I have heart failure symptoms and was hospitalized for it in the last year.
SELFIe-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with cardiovascular (CV) death
Number of Participants with hospital admission for heart failure
Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic
+1 moreSecondary outcome measures
Change in 6 minutes walk distance
Change in Quality of life
Change in functional capacity between baseline and 12-months
+6 moreSELFIe-HF Trial Design
2Treatment groups
Active Control
Group I: CardioMemsActive Control1 Intervention
The treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.
Group II: ControlActive Control1 Intervention
Heart failure clinic follow up
Find a Location
Who is running the clinical trial?
Montreal Heart InstituteLead Sponsor
120 Previous Clinical Trials
68,669 Total Patients Enrolled
Anique DucharmePrincipal InvestigatorMontreal Heart Institute
Jean Rouleau, MDStudy DirectorMontreal Heart Institute
1 Previous Clinical Trials
224 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had heart failure for at least 3 months.My pulmonary artery size and my body structure meet the specific requirements.I have heart failure symptoms and was hospitalized for it in the last year.I've been to the ER or had an unplanned heart failure clinic visit needing IV diuretics, with high NT-proBNP levels and am on strong diuretics or have severe heart symptoms.I am 18 years old or older.I have severe heart failure, may have a heart pump, or am waiting for a heart transplant.I've had a recent heart issue or stroke, or I'm scheduled for heart surgery.I have had a pulmonary embolism or recurrent deep vein thrombosis.Criterion: You have unstable health conditions that make it difficult to monitor you from a distance or participate in the study. This could include very high or very low blood pressure, severe kidney disease, severe pulmonary hypertension, anemia, blood clotting issues, ongoing infections, pregnancy, or other serious health problems that could affect the study's evaluation.I do not have severe heart valve issues, infections, or significant swelling around my heart.
Research Study Groups:
This trial has the following groups:- Group 1: CardioMems
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has recruitment progressed for this trial?
"Affirmative. Clinicaltrials.gov has records of this clinical trial actively recruiting particpants, which was initially published on May 4th 2020 and last modified October 5th 2022. In total, 150 patients are required from one medical centre to complete the study."
Answered by AI
Is participation in this research study currently available to volunteers?
"Affirmative. Clinicaltrials.gov demonstrates that this medical trial is actively recruiting patients, first registered on May 4th 2020 and most recently updated on October 5th 2022. The research team needs to enlist 150 participants at 1 facility for the study's completion."
Answered by AI
What is the primary goal of this medical experiment?
"The primary outcome of this medical trial, with measurements taken over a year-long period, is the initial instance of any element in the composite event. Other objectives include evaluating changes to pulmonary artery pressures via CardioMems technology; assessing adverse events related to the device; and observing alterations in functional capacity between baseline and post-treatment (utilizing NYHA's cardiomyopathy questionnaire)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger