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Device
Cordella™ Sensor System for Heart Failure (PROACTIVE-HF Trial)
N/A
Waitlist Available
Research Sponsored by Endotronix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader
Male or female, at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
PROACTIVE-HF Trial Summary
This trial will compare the safety and effectiveness of a new heart failure sensor to a performance goal.
Who is the study for?
This trial is for adults with NYHA Class III Heart Failure who've been on stable heart failure therapy for at least 30 days and have had a recent hospital visit or high NT-proBNP levels. They must be able to use the myCordella™ Patient Reader device daily, have good internet at home, and commit to follow-up visits. Excluded are those with severe kidney issues, non-compliance history, certain cardiovascular events within 3 months, specific intolerances or allergies, active infections, pregnancy/breastfeeding, or other life-limiting severe illnesses.Check my eligibility
What is being tested?
The Cordella PA Sensor System is being tested in this study. It's an open-label trial where all participants receive the sensor system designed to monitor their heart failure status compared against a performance goal set by previous data.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from using the device daily and risks associated with any invasive procedure like infection or bleeding since it involves implantation of a sensor.
PROACTIVE-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can hold a 1.3lb device against my chest for 2 minutes daily and dock it.
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I am 18 years old or older.
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I have been on a stable heart failure treatment for at least 30 days.
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I am currently taking water pills.
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I have been hospitalized or needed urgent care for heart failure in the last year.
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I can see, hear, and understand well enough to use a medical device.
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I have been diagnosed and treated for heart failure for at least 3 months and am currently experiencing moderate heart failure symptoms.
PROACTIVE-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hyalinosis, Systemic
Safety: Freedom from device/system related complication
Safety: Freedom from pressure sensor failure
Secondary outcome measures
Days Alive and Out of Hospital (DAOH)
Device success
Perinatal death
+15 morePROACTIVE-HF Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) and Guideline Directed Medical Therapy (GDMT) considering daily Pulmonary Artery Pressure (PAP) measurements and vital signs collected by Cordella Heart Failure System (CHFS).
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Who is running the clinical trial?
Endotronix, Inc.Lead Sponsor
4 Previous Clinical Trials
1,753 Total Patients Enrolled
4 Trials studying Heart Failure
1,753 Patients Enrolled for Heart Failure
Andrea SauerlandStudy DirectorEndotronix, Inc.
4 Previous Clinical Trials
1,753 Total Patients Enrolled
4 Trials studying Heart Failure
1,753 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
University of Mississippi
Ascension St Vincent's
How many prior treatments have patients received?
3+
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