Your session is about to expire
← Back to Search
Procedure
Interatrial Shunt for Heart Failure
N/A
Waitlist Available
Research Sponsored by Alleviant Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month and through 12 months
Awards & highlights
Study Summary
This trial will evaluate whether a new treatment for heart failure, a no-implant interatrial shunt, is effective in patients with preserved or mid-range left ventricular ejection fraction and mild to moderate functional limitation.
Who is the study for?
This trial is for heart failure patients who've been hospitalized or needed IV diuretics in the past year, have a left ventricular ejection fraction over 40%, and experience mild to moderate limitations in daily activities. They must not be on a transplant list, have severe valve or lung disease, require dialysis with very low kidney function, walk too little or too much during a test, have uncontrolled atrial fibrillation, severe right heart issues, certain pulmonary hypertension levels, anatomic anomalies preventing shunt creation, or extremely high blood pressure.Check my eligibility
What is being tested?
The Alleviate-HF-2 Study tests if creating a no-implant interatrial shunt can improve conditions for those with heart failure and preserved/mid-range left ventricular ejection fraction. It uses clinical assessments along with echocardiographic and invasive hemodynamic data to evaluate treatment effectiveness.See study design
What are the potential side effects?
While specific side effects are not listed here, procedures involving the creation of an interatrial shunt may include risks such as bleeding complications at the catheter site; irregular heartbeat; infection risk; potential shortness of breath increase due to altered blood flow between heart chambers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month and through 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month and through 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The composite incidence of one or more major adverse cardiac, cerebrovascular and thromboembolic events and change in supine exercise PCWP at peak exercise.
Find a Location
Who is running the clinical trial?
Alleviant Medical, Inc.Lead Sponsor
4 Previous Clinical Trials
525 Total Patients Enrolled
4 Trials studying Heart Failure
525 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are waiting for a heart transplant.You have a history of moderate to severe heart failure, as determined by your doctor.You have severe heart failure based on certain criteria.Your heart is not pumping enough blood for your body's needs.You have received a specific type of medication for a weak heart in the past 6 months.You have a heart valve problem that's not mild.You have a long-term lung disease that meets certain criteria.You need dialysis or your kidney function is very low.You can walk for only a very short distance or a very long distance in 6 minutes.You have been diagnosed with atrial fibrillation and your heart rate is higher than 100 beats per minute during screening.You have moderate or severe dysfunction in the right side of your heart, or specific problems with the right ventricle as determined by certain criteria.You have high blood pressure in the lungs, confirmed by specific tests.You have a physical abnormality that prevents the creation of a hole between the upper chambers of your heart.Your blood pressure is higher than 170 mmHg at the time of screening.Your heart's left ventricle is larger than 6 cm when it's filled with blood.Your heart's pumping ability is good, as shown by a specific heart ultrasound test.You have been hospitalized for heart failure or received IV diuretics for heart failure in the past year.A special heart test shows that your heart is not filling up with blood properly.Your heart pressure is too high on one side compared to the other, as shown by a special test called right heart catheterization.
Research Study Groups:
This trial has the following groups: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.
Is participation in this research endeavor still obtainable for interested individuals?
"Based on the information hosted by clinicaltrials.gov, this research project is not actively seeking subjects at present. The study was first made available to the public on April 3rd 2021 and most recently modified on July 26th 2022. Although the trial has already been filled with participants, there are currently 701 other trials enrolling volunteers."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger