Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry, or one emergency department visit with IV treatment for HF within the 12 months prior to study entry
Trans-septal catheterization by femoral vein access is determined to be feasible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new heart failure treatment in people who remain symptomatic despite other treatments. The goal is to see if it is safe and effective.
Who is the study for?
Adults over 18 with chronic heart failure, NYHA Class III/IV symptoms, and a history of hospitalization for heart failure. They must have reduced heart function (20-40% ejection fraction) and elevated left atrial pressure despite stable medication treatment. Excluded are those with recent cardiac procedures or devices, uncontrolled arrhythmias or blood pressure, severe lung disease, allergies to nickel, potential childbearing women without contraception use, significant liver impairment or life expectancy less than a year due to other diseases.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of an IASD implant in patients with symptomatic heart failure who still have high left-sided heart pressures despite being on standard medications. The device aims to balance the pressures between the left and right sides of the heart.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, risk of infection from surgery, allergic reactions to materials in the device such as nickel if applicable, irregular heartbeat risks associated with catheter-based procedures and possible impact on blood flow dynamics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was hospitalized or visited the ER for heart failure and received IV treatment in the last year.
Select...
A procedure to reach my heart through a vein in my leg is possible.
Select...
I have chronic heart failure with NYHA Class III or ambulatory IV symptoms in the past year.
Select...
I am on a stable heart failure medication plan as per the 2016 guidelines.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percent of subjects left to right flow through the device
The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE)
The percent of subjects who have successful device implantation
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
IASD Implantation
Find a Location
Who is running the clinical trial?
Corvia MedicalLead Sponsor
7 Previous Clinical Trials
1,977 Total Patients Enrolled
7 Trials studying Heart Failure
1,977 Patients Enrolled for Heart Failure
Jan Komtebedde, DVMStudy DirectorCorvia Medical
2 Previous Clinical Trials
75 Total Patients Enrolled
2 Trials studying Heart Failure
75 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your NT-Pro BNP or BNP levels are within certain ranges depending on your heart rhythm.My heart's right side is not working properly.I was hospitalized or visited the ER for heart failure and received IV treatment in the last year.A procedure to reach my heart through a vein in my leg is possible.I have severe heart issues and cannot walk far without getting tired.I have atrial fibrillation with a resting heart rate over 100 BPM.I have severe liver problems.I need home oxygen or have serious lung disease.I am a woman who can become pregnant.I have chronic heart failure with NYHA Class III or ambulatory IV symptoms in the past year.I am currently on immunosuppressants or systemic steroids.I am not on standard heart medication for specific reasons.You are allergic to nickel or think you might be.Your left atrial pressure is too high compared to your right atrial pressure.I started heart rhythm therapy within the last 3 months.Your blood pressure is higher than 170 mmHg even with medication.You have a serious problem with one of your heart valves, as seen in a special heart test called an echocardiogram.You have signs of high blood pressure in the lungs.I cannot take certain blood thinners or have a bleeding disorder.Your resting RAP is higher than 14 mmHg.My heart's pumping ability is reduced, with an ejection fraction between 20% and 40%.I have had a heart attack or heart surgery in the last 3 months.I am on a stable heart failure medication plan as per the 2016 guidelines.I have a heart condition that was either born with or surgically treated.I am on dialysis or my kidney function is very low.Your blood oxygen level is less than 95% when breathing normal air.I am 18 years old or older.You are not expected to live for more than 12 months due to reasons other than heart problems.You have signs of a mass, clot, or growth inside your heart seen on an echocardiogram.You have had a heart device called an AICD implanted in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
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.
Are individuals still being accepted to partake in this trial?
"The data hosted on clinicaltrials.gov states that this research endeavour is not presently enrolling subjects; the project was first posted on March 10th 2017 and most recently updated on April 7th 2022. Despite this, 702 other medical trials are actively recruiting now."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger