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Cordella™ Sensor System for Heart Failure (PROACTIVE-HF Trial)
PROACTIVE-HF Trial Summary
This trial will compare the safety and effectiveness of a new heart failure sensor to a performance goal.
PROACTIVE-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROACTIVE-HF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROACTIVE-HF Trial Design
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Who is running the clinical trial?
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- I can hold a 1.3lb device against my chest for 2 minutes daily and dock it.I have not had a major heart event like a heart attack or stroke in the last 3 months.I am likely to get an advanced therapy like a heart or lung transplant soon.I am 18 years old or older.You have a current infection when the sensor is put in.I am allergic to common blood thinners like aspirin.I have been on a stable heart failure treatment for at least 30 days.I cannot tolerate certain heart medications due to low blood pressure or kidney issues.I have a serious heart valve problem that hasn't been fixed.I have advanced heart failure and may be on medication to help my heart pump.I do not have a severe illness limiting my life expectancy to less than a year.I am currently taking water pills.I have been hospitalized or needed urgent care for heart failure in the last year.I am willing and able to follow the study's requirements.I got a CRT device implanted less than 3 months ago.I can see, hear, and understand well enough to use a medical device.You have a serious heart condition that hasn't been fixed and would make it hard to put in the Cordella PA sensor or heart valve.You are currently participating in another research study that involves receiving treatment.I have a known blood clotting disorder.I have been diagnosed and treated for heart failure for at least 3 months and am currently experiencing moderate heart failure symptoms.My kidney function is very low or I am on long-term dialysis.You cannot have a right heart catheterization.I have had 2 or more lung clots or a recent deep vein clot.
- Group 1: Treatment Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the primary aims of this empirical research?
"This medical trial will be supervised for a year in order to assess the safety of the pressure sensor. Ancillary goals include tracking HF Hospitalization and Emergency Department/Hospital Outpatient IV diuretic visits at 6 months and 12 months, monitoring implant procedure-related adverse events and serious outcomes, as well as assessing functional status improvement through NYHA measures and 6-Minute Walk Test scores."
How many healthcare facilities are administering this research experiment?
"87 locations are presently enrolling patients for this trial, located in cities such as Minneapolis, Austin and Nashville. To reduce travel needs during participation, it is ideal to pick a clinical site the closest to you."
Are researchers currently accepting participants for this experiment?
"Affirmative. Clinicaltrials.gov lists this trial as actively recruiting, beginning from its posting on October 1st 2020 and updated most recently in November 11th 2022. This research is aiming to enrol 450 individuals at 87 distinct medical sites."
What is the current size of this research project's population?
"This trial necessitates 450 eligible participants from two distinct locations. Specifically, Minneapolis Heart Institute Foundation in Minnesota and The Heart Hospital of Austin (Austin Heart) located in Texas are both open for enrolment."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
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